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

Model Number CAT.11460-010T

Device Problem Burst Container or Vessel (1074)

Patient Problem Insufficient Information (4580)

Event Date 07/17/2021

Event Type  malfunction  

Event Description

As patient care assistant was squeezing cardinal health infant heel warmer to activate it, a side seam burst open and the contents spilled on the inside of the crib, hand rail of the baby crib and on the floor.Fda safety report id # (b)(4).

• Brand Name: CARDINAL HEALTH INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC.
• MDR Report Key: 12210758
• MDR Text Key: 263195622
• Report Number: MW5102702
• Device Sequence Number: 1
• Product Code: MPO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2021

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: No Information
• Device Model Number: CAT.11460-010T
• Device Catalogue Number: 11460-010T
• Device Lot Number: V1E144 B
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1