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

Model Number MH00002T

Device Problem Material Rupture (1546)

Patient Problem Eye Injury (1845)

Event Date 01/24/2020

Event Type  Injury  

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 when preparing to use a heel warmer for an infant patient, the phlebotomist turned her back to the infant and its mother to squeeze the heel warmer as instructed by the packaging.When she squeezed the packaging, the packaging exploded with its contents.The contents of the packaging landed on the wall she was facing and splashed back into her eyes.The phlebotomist stated that her eyes began to burn.The phlebotomist was sent to the employee health nurse to be evaluated.

Manufacturer Narrative

The device history record (dhr) was not performed during this investigation as the lot number was not received with the complaint.All dhr¿s are reviewed and approved by quality prior to the release of the product.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.During the test, the pouch is first activated, the inner seal is broken.The pouch is then placed between two plates.The pouch is compressed until the pressure required per the procedure is reached, 350 lbs.Minimum.The pouch is left to dwell in the machine for 20 seconds, using a calibrated stopwatch to time it.After the dwell time the pouch is removed and visually inspected for leaks or spreading of the seam.A pouch with any deficiency would be rejected at this time and the machine adjusted.If the pouch passes the dwell test it is returned to the machine and the pouch is the compressed until the pouch breaks or reaches over 1000 pounds.A sample has not been received for analysis.Without a sample we are unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause(s) of the reported condition or implement any corrective action(s).While a definitive root cause could not be determined without a 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 by the clinician 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.

• 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: 9650387
• MDR Text Key: 177159490
• Report Number: 1219103-2020-00253
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 01/27/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 01/27/2020
• Supplement Dates FDA Received: 04/24/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other