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 No Consequences Or Impact To Patient (2199)

Event Date 05/21/2020

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that several heel warmers have exploded when squeezed to activate going all over the nursery, equipment and cribs.There was no patient injury.

Manufacturer Narrative

The device history records (dhrs) were reviewed, 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, this includes 60 physical inspections of the outer seal strength.There were no samples received with this complaint therefore an examination of the defect could not be made.Per the complaint report samples are expected.If sample is received at a later date, this complaint will be reopened for further investigation.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 introduced where the artwork is rotated 90 degrees and the top of the pouch is processed through vertical seal bars.Relative to the finished pouch, the top, bottom and inner seals are created using vertical bar sealers.As the machine moves the materials, the side seals are created using another bar sealer.During the sealing processes, a set of 4 pouches are formed during a machine cycle with 2 pouches from lane 1 and 2 pouches from lane 2.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 water and sodium acetate anhydrous to be dispensed and the pouch seal to be completed around it.An investigation into activities associated with the manufacture of the product showed that the material alignment is the most likely cause of the defect 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.Tests are performed in accordance with our procedures and acceptable quality limits.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 defects 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.The value is recorded.The results of the manufacturing facility investigation were able to identify the most probably cause of the reported condition to be 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 has been opened to verify the root cause and determine actions to prevent recurrence of the issue.We 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): COVIDIEN; 2 ludlow parkway; chicopee MA 01022
• MDR Report Key: 10157572
• MDR Text Key: 195241485
• Report Number: 1219103-2020-00295
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

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
• Device Lot Number: 010572X
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/21/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 05/21/2020
• Supplement Dates FDA Received: 07/09/2020
• Patient Sequence Number: 1