MAUDE Adverse Event Report: COVIDIEN LP INFANT HEEL WARMER; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Lot Number CH42SP10604

Device Problems Leak/Splash (1354); Explosion (4006)

Patient Problem Chemical Exposure (2570)

Event Date 12/29/2020

Event Type  malfunction  

Event Description

Nurse was in the process of activating an infant heel warmer to prepare for a blood glucose.During the activation process the warmer exploded and spewed its contents on the nurse and many objects in the vicinity including the father of baby.

• Brand Name: INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): COVIDIEN LP; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 11193103
• MDR Text Key: 227517195
• Report Number: 11193103
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: CH42SP10604
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1