MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC INFANT HEEL WARMER,SQUEEZE, 4X4IN; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number 11460-010T

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/1980

Event Type  malfunction  

Manufacturer Narrative

Device history review was completed on the reported lot v2c242.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.Sample was not returned for evaluation due to which a root cause could not be determined.We will continue to monitor trends for this product.

Event Description

Customer reported that infant heel warmer popped open at the seal upon activation.No adverse event was reported.Event date was not provided.No further information was provided.

Manufacturer Narrative

Supplemental report is being filed following the submission of the initial mdr report submitted on 6/7/2022 since the results of investigation are available.Device history record review was completed on the reported lot v2c242.The lot was found to have been manufactured and released to predetermined specifications.We received 1 sample for evaluation.The sample was already activated.From the investigation, the root cause was determined to be an incomplete top seal.This was determined to be due to setup issues resulting from an inadequate procedure.A quality alert was posted and trained on to ensure the setup was done properly on the infant heel warmer line.Standard production methods will be updated.Cardinal will continue to monitor trends for this product.

• Brand Name: INFANT HEEL WARMER,SQUEEZE, 4X4IN
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 14627622
• MDR Text Key: 301241838
• Report Number: 1423537-2022-00778
• Device Sequence Number: 1
• Product Code: MPO
• UDI-Device Identifier: 10630140017391
• UDI-Public: 10630140017391
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/13/2022

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: Health Professional
• Device Model Number: 11460-010T
• Device Catalogue Number: 11460-010T
• Device Lot Number: V2C242
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1