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 06/24/2022

Event Type  malfunction  

Manufacturer Narrative

Device history review was completed on the reported lot number, v2e092.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.The actual customer sample was not returned for evaluation; therefore, a root cause could not be determined.We will continue to monitor trends for this product.

Event Description

Customer reported that when the infant heel warmer was squeezed to activate, it burst and squirted out all over infant¿s leg.There was no injury or adverse effect reported, contents removed with infant wipes.

• 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: 15062334
• MDR Text Key: 304518851
• Report Number: 1423537-2022-00805
• 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: Other
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/09/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1