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	04/10/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that all the contents of the product spilled onto the nurse and the floor.There was no injury reported.
Additional Manufacturer Narrative
Additional information: the device history record (dhr) was reviewed for two possible lot numbers and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review shows that all acceptance criteria inspections were within acceptable limits during the production process.There were no samples received with this complaint therefore an examination of the reported condition could not be made.An investigation into activities associated with the manufacture of the product showed that the material alignment is the most likely cause of the reported condition.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.The results of the manufacturing facility investigation were able to identify the most probable cause of the issue is associated with the manufacturing process.A quality alert has been issued for awareness of the 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: 9988997
• Report Number: 1219103-2020-00286
• Device Sequence Number: 11812986
• 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): 07/06/2020

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
• 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: 07/06/2020
• Patient Sequence Number: 1