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

Model Number 11460-010T

Device Problem Burst Container or Vessel (1074)

Patient Problem Insufficient Information (4580)

Event Date 07/21/2022

Event Type  malfunction  

Event Description

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 the child's mother.

• Brand Name: CARDINAL HEALTH
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 15137958
• MDR Text Key: 296957141
• Report Number: 15137958
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/22/2022

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: Other
• Device Model Number: 11460-010T
• Device Catalogue Number: 11460-010T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1