MAUDE Adverse Event Report: MA028 MA-CHICOPEE "WARMERS, INFANT HEEL W/TABS"; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number MH00002T

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2020

Event Type  malfunction  

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 Description

The customer reported that she was in their warehouse and the warmer burst open.Minimal force was used to attempt to activate the warmer.

Manufacturer Narrative

A review of the device history record was not performed during this investigation as the lot number was not received with the complaint.All device history records are reviewed and approved by quality prior to release of product.Since a lot number was not provided and the customer returned sample does not have a lot number, information such as the test results, quantity manufactured, and date of manufacture could not be determined.Samples were received from the customer in the form of four heel warmer pouches.One pouch had been previous activated with no visual deficiency.One pouch had not been previously activated, meaning the inner seal was still intact but there was activated product in the pouch.When the inner seal was popped, the heel warmer did not get hot as it is supposed to.The other two pouches showed no visible defects.The quality engineer squeezed each of the pouches to activated them.Each of the pouches burst and released the warming fluid.The hole was an approximately 0.375-inch open section just over.50 inches from the left edge of the pouch.While a definitive root cause could not be determined from the customer returned sample, a likely contributor for this issue is as the vertical sealer bar is sealing the top of two consecutive pouches, there could be a localized weak region just prior to the midpoint of the vertical sealer bar causing an incomplete seal.Additionally, there could have been some type of buildup on the sealer bars that would cause a localized weak spot.Relative to the issue reported by the customer, pressure was applied and this area of the pouch broke open.The results of the manufacturing facility investigation were able to identify a localized area of the pouch that was the likely area where the pouch contents leaked out of.A review of maintenance activity noted that the sealer bars were dirty and worn and were therefore cleaned and replaced.The operator¿s preventive maintenance (pm) guide has been updated to include a visual inspection and cleaning of all sealer bars and dies every month during regular pm¿s.

Manufacturer Narrative

Additional information: 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"
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): MA028 MA-CHICOPEE; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 9623374
• MDR Text Key: 176418267
• Report Number: 1219103-2020-00252
• 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: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2020

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
• Device Operator: No Information
• Device Model Number: MH00002T
• Device Catalogue Number: MH00002T
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/21/2020
• Initial Date FDA Received: 01/23/2020
• Supplement Dates Manufacturer Received: 01/21/2020; 01/21/2020
• Supplement Dates FDA Received: 03/18/2020; 11/19/2020
• Patient Sequence Number: 1