MAUDE Adverse Event Report: COVIDIEN "WARMERS, INFANT HEEL W/TABS"; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number	MH00002T
Medical Device Problem Code	Explosion (4006)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that the product had popped and the contents sprayed onto the baby.There was no injury reported.
Additional Manufacturer Narrative
Additional information: the device history record (dhr) was reviewed for the possible lot numbers given, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition as described by the customer.The dhr review shows that all acceptance criteria inspections were within acceptable limits during the production process, a sample in the form of a photo in the complaint report shows the heel warmer pouch and the hand and clothing of a person which are covered with the chemical mixture.An investigation into activities associated with the manufacture of the product showed that the material alignment is the most likely cause of the issue as described.The clear liner and white liner should be lined up together and sealed in the sealer bars.If the material is not lined up correctly it can cause a weak seal, as there would not be enough material to complete a full seal.It is not always possible to immediately see the issue as one of the materials is clear.It has been determined there are indicators within the manufacturing process which will assist in verifying the materials are lined up correctly.It is also important to note that a series of tests are performed during every lot of production.More specifically, inspections are performed to test the seal strength for both the inner seal, where the product would activate and the outer seal.A pouch with any issues would be rejected at this time and the machine adjusted.The results of the manufacturing facility investigation were able to identify the most probably cause of the reported condition is associated with the manufacturing process.A quality alert has been issued for awareness to some indicators of mis-aligned material.A corrective and preventative action (capa) has been opened to verify the root cause and determine actions to prevent recurrence of the issue.The manufacturing site will continue to trend this issue for future occurrences as part of the complaint review process.

• Brand Name: "WARMERS, INFANT HEEL W/TABS"
• Common Device Name: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 9988936
• Report Number: 1219103-2020-00284
• Device Sequence Number: 4203256
• Product Code: MPO
• UDI-Device Identifier: 30884527004632
• UDI-Public: 30884527004632
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: MH00002T
• Device Catalogue Number: MH00002T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 11/19/2020
• Patient Sequence Number: 1