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 Known Impact Or Consequence To Patient (2692)

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 the infant heel warmer pack exploded when it was squeezed for activation.The activated gel projected out onto the care provider.This occurred prior to placement on the infant.

Manufacturer Narrative

Please note: section h6 reflects 10 and 4101 as the customer returned the actual device along with 19 other samples.However, it cannot be confirmed if the samples are from the same lot/batch as the customer was unable to provide any lot numbers.A review of the device history record was not performed during this investigation as a lot number was not received with the complaint.All device history records are reviewed and approved by quality prior to release of product.Twenty samples were received at the manufacturing site for the investigation.A visual inspection was performed on each sample.19 of the samples showed a hole in the top left (as you look at the back of the pouch) or full top of the clear side of the pouch.1 sample showed pre-activation with no hole in the heel warmer pouch.The reported condition was confirmed.Visual inspection of the front (white) side of the pouch determined the product is from lane 1 of the production line as there is a 1 printed on the pouch in the lower left corner on the front of the pouch.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.While a definitive root cause cannot be determined without a lot number being provided, a likely contributor to this issue is something localized with the vertical sealer bar in the vicinity of the hole.As the vertical sealer bar is sealing the top of two consecutive pouches from lane 1, there could be a localized weak region just prior to the midpoint of the vertical sealer bar or the end of the sealer bar if it were the second pouch being sealed.The sealer bar could have caused a weak spot at the edge of the 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.For the pre-activation the cause is most likely powder residue was caught in the seal and pre-activated the pouch during shipment.An investigation into activities associated with the manufacturing line took place in november of 2019 and the operator noted leaking of pouch contents on the machine.During the inspection of the machine, the maintenance technician found that the horizontal sealer bars and coating were worn.The inspection also showed that the vertical sealer bars were dirty and were creating ¿pinholes.¿ the technician noted they were able to clean the vertical seal bars/masks.The following day, the vertical die was replaced when leaks were noted again.The machine operator verbally indicated samples were inspected after the bars were cleaned and replaced, with no issues found.As noted previously, without a lot number, a definitive statement cannot be made.It is also important to note that quality took samples from the machine during this investigation and was unable to recreate the defect as reported with the machine running with the clean vertical sealer bar, a new horizontal sealer bar and a new die.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, and 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 issues 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 then compressed until the pouch breaks or reaches over 1000 pounds.The value is then recorded.No further corrective actions are applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.We will continue to trend this issue for future occurrences as part of the complaint review process.This complaint will be used for qa 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: 9856193
• MDR Text Key: 184150085
• Report Number: 1219103-2020-00273
• 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: 05/04/2020

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: 03/02/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 03/02/2020
• Supplement Dates FDA Received: 05/04/2020
• Patient Sequence Number: 1