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 07/21/2022

Event Type  malfunction  

Event Description

Customer reported a heel warmer was obtained to perform a heel stick.Upon squeezing the sides of the heel warmer, per instruction, the liquid exploded out the top.The liquid landed on the lab tech.According to the witness statement, "the heel warmer "exploded all over" the employee.Per her supervisor, the pack material hit her neck and scrub top.She changed her clothes, and no injury was reported.No demographic information provided.

Manufacturer Narrative

Review of the device history report was completed on the reported lot number, v2c227.The lot was found to have been manufactured on 3/23/22 and released to predetermined specifications.Maintenance records were also reviewed.No anomalies were found during review of the records.No physical samples were returned due to which a root cause could not be determined.Sample photos were reviewed, but we are still not able to determine a root cause based on evaluation of photos.Cardinal health will continue to monitor complaint trends for this issue.

• 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: 15301841
• MDR Text Key: 303303035
• Report Number: 1423537-2022-00829
• 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: 08/26/2022

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/23/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female