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Tommy Tippee Pacifier, closer to Nature, 0-6 month
Baby
Nursery Equipment & Supplies
Pacifiers or Teething Rings (1525)
MAYBORN USA INC    
Tommy Tippee
533036
 
 
Babys R Us
Unspecified
6/15/2011 This date is an estimate
Tommy Tippee, Closer to Nature Pacifier 0-6 Month

Found broken pacifier on high chair tray after child spit it out. The broken edge was found on the floor. The broken piece is about 3/4 of an inch long. Also left scratches on child's cheek. The broken edge is very sharp.
12/4/2011
Home/Apartment/Condominium 
Injury→Injury, No First Aid or Medical Attention Received
My Child
Male
0 years 6 months
Yes
No
No
waiting to see if the manufacture wants the product for testing.
No
Yes
Comment from MAYBORN USA INC 12/22/2011
The complaint is in relation to the Mayborn Baby and Child product under the brand name Tommee Tippee CTN 0-6 Months Style Pacifier. This product can be identified under the product code 533036 and is retailed via Babies R Us.

Mayborn Baby & Child received the Soother on the 15th December 2011. The damage to the product is that part of the soother shield had broken from the main shield body. Scuff marks could also be seen on the product. The other side of the shield had very small hailine cracks.

Below is comment on the process and specifications used to ensure complete compliance to the regulations in regards to these products.

Specific points referred to in the complaint.

Consumer states ‘‘Found broken pacifier on high chair tray after child spit it out. The broken edge was found on the floor. The broken piece is about 3/4 of an inch long. Also left scratches on child's cheek. The broken edge is very sharp.’
‘Purchase date: 6/15/2011. This date is an estimate’
As discussed with the Consumer via our Careline ‘The pacifier was purchased 3 months ago and has been used since. Her baby is 5 months old and it was a stage 1 style pacifier’

Mayborn Baby and Child Response – Product Integrity.

The Style Pacifier - 0-6 Months in question has been tested and certified in accordance with 16 CFR 1500.48, 49, 50, 51, 52 and 53. The test methods defined within these specific standards are designed to simulate reasonable foreseeable use and abuse of toys and other articles intended for use by children up but not over 36 months of age.

Section C of 16 CFR 1500 parts 51, 52 and 53, details the “Bite Testing” requirements for simulation of use and abuse testing. In addition to us testing internally to these standards we have also used the services of an independent test laboratory (SGS) to validate the product for compliance. The results of this compliance testing is detailed in test report SZTYR101032192TS (see attached) and shows the product to be compliant with all the requirements of the regulation.

In addition the product complies with ASTM F963-08 Standard Consumer Safety for Toy Safety and 16 CFR 1511 Requirements for Pacifiers

Further to the above regulatory requirements, Mayborn Baby and Child also test this product to our own in house testing protocols which go above and beyond those defined within the regulation, These additional in house requirements are detailed in table 1 below and are intended to ensure the selection of the most suitable, reliable and durable materials for these applications.

Table 1 - Specific comparison of Mayborn Baby and Child Internal Testing requirements and the 16 CFR 1500 requirements relating to biting and tearing abuse testing and simulated stand on test.

Torque and Tension
– Mayborn Internal Acceptance Criteria- >1.00NM torque and >100 Newtons in tension
- CFR1500.51,52 & 53 Test Requirement - 0.23 to 0.45 NM torque and 44.5 to 66.8 Newtons in tension
Mayborn internal testing levels are 3 times higher for torque and almost double the tension requirement of the 16 CFR 1500

Bite
- Mayborn Internal Acceptance Criteria - >200 Newtons for a minimum of 10 cycles, 90 Newtons for a minimum of 400 cycles
- CFR1500.51,52 & 53 Test Requirement - CFR 1500.51 – 111.5 Newtons for 1 cycle, CFR 1500.52 –
222.5 Newtons for 1 cycle, CFR 1500.53 – 445 Newtons for 1 cycle
The Mayborn product meets the CFR requirements, however Mayborn introduced additional specific tests to assess the material durability at a lower force of 90N but over 400 cycles to simulate further abuse conditions

Bite and Tear
- Mayborn Internal Acceptance Criteria - A bite force of >200 Newtons is applied and a force of 90 Newtons perpendicular to the bite direction is applied, no separation of small parts is acceptable
- No comparable defined criteria defined under 16 CFR 1500
Mayborn defined a specific test to simulate the child’s biting and tearing action. The product material selection must meet this requirement.

Simulated Stand On Test
- Mayborn Internal Acceptance Criteria - A force of >400 Newtons is applied through a flat surface plate.
- No comparable defined criteria defined under 16 CFR 1500
Mayborn defined a specific test to simulate standing on the pacifier. The product material selection must meet this requirement.

Mayborn Baby and Child have therefore considered the aspects of the 16 CFR 1500 requirements and have engineered the product to these standards. Additionally we have conducted testing which proves we have considered additional foreseeable use and abuse conditions which specifically target the ability of the product to withstand biting and tearing over time by the child and additionally a simulated stand on test.

Mayborn Baby and Child Response – Product Instructions.

The product point of sale packaging carries the following statement-

“Please keep this instruction sheet for future reference as it includes important information’

With the instructions for use which are indicated on the point of sale packaging there are detailed within the test specific warnings and usage instructions, these instructions include-

1. Inspect carefully before each use, especially when the child has teeth. Pull the pacifier in all directions.
2. Throw away at first signs of damage or weakness.
3. Replace the pacifier after one month, for safety and hygiene reasons.

Summary
While Mayborn Baby and Child do not dispute the issue raised by the consumer to the CPSC we can confirm via external testing that the product in question complies with the regulatory requirements of 16 CFR 1500 in relation to abuse testing for children up to but not over 36 months. Our own internal test methods increase the acceptance criteria of the product further and introduces the requirement for simulated stand on testing to prove the design integrity and reliability of this product.

As a responsible manufacturer we continuously review our product design to determine if further improvements can be made and will continue to do so. However Mayborn Baby and Child must point out that for this incident to have occurred the product has been used in ways beyond the regulatory abuse tests defined within the CFR requirement and our own defined durability testing. In addition to these unusual usage characteristics the warnings included with the product appear not to have been fully considered by the consumer.
File NameDescription
IMG_0580.JPG Broken Pacifier

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