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 04/27/2022

Event Type  malfunction  

Event Description

Customer reported upon activation, the infant heel warmer burst at the seams exposing hot gel contents onto the nurse¿s face and hands.Contents was washed off with water.There was no injury to the nurse.

Manufacturer Narrative

Device history review was completed on the reported lot number v2b110.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the record.No sample was returned for investigation, therefore, an evaluation of the complaint device for deficiency of construction could not be performed.We are unable to determine a specific assignable root cause for the reported incident.We will continue to monitor this failure mode 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 dr; 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: 14467485
• MDR Text Key: 300347494
• Report Number: 1423537-2022-00768
• 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: 05/22/2022

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: V2B110
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2022
• Initial Date FDA Received: 05/22/2022
• Date Device Manufactured: 02/10/2022
• 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
• Patient Sex: Female