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

Model Number MH00002T

Device Problem Explosion (4006)

Patient Problem Insufficient Information (4580)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the infant heel warmer exploded in associate's face when trying to activate.The customer reported that intervention was required but no other details were provided.On (b)(6) 2021, the customer stated there is no additional information available.

Manufacturer Narrative

Additional information: a review of the device history record (dhr) was not performed during this investigation as a viable lot number was not available.All dhrs are reviewed and approved by quality prior to release of product.There were no samples received with this complaint therefore an examination of the reported condition could not be made.The product is manufactured using a dispense of contents and both horizontal and vertical sealing processes.Two printed polybag liners (front and back) are lined up and sealed.The materials are sealed and cut apart to make four separate pouches during a cycle.The sealers are set up to seal the liners together as they run vertically through the line.This allows for the contents to be dispensed and the pouch seal to be completed around it.From a root cause perspective, with no lot number it is not possible to determine if there were issues during production which could have resulted in a weak seal.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.Tests are performed in accordance with procedure.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 possible causes associated with the manufacturing process.A corrective and preventative action (capa) has been opened for issues regarding burst pouches.The capa aims to investigate sealing and material issues on the line.A quality alert has been issued for awareness to the failure.The manufacturing site will continue to trend this issue for future occurrences as part of the complaint review process.This complaint will be used for tracking and trending purposes.

• Brand Name: WARMERS, INFANT HEEL W/TABS
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 11408054
• MDR Text Key: 234602746
• Report Number: 1219103-2021-00317
• Device Sequence Number: 1
• Product Code: MPO
• UDI-Device Identifier: 30884527004632
• UDI-Public: 30884527004632
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MH00002T
• Device Catalogue Number: MH00002T
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 03/02/2021
• Supplement Dates FDA Received: 04/27/2021
• Patient Sequence Number: 1