MAUDE Adverse Event Report: CARDINAL HEALTH HEEL INFANT WARMER; WARMER INFANT RADIANT

Catalog Number 11460-010T

Device Problem Burst Container or Vessel (1074)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Cardinal health infant heel warmers are bursting at the seam when being activated; contents of warmer has made contact with patients and staff.We have had over a half dozen incidents of this type from different lots number of the same product.

• Brand Name: HEEL INFANT WARMER
• Type of Device: WARMER INFANT RADIANT
• Manufacturer (Section D): CARDINAL HEALTH; montgomery NY 12549
• MDR Report Key: 6776725
• MDR Text Key: 82376514
• Report Number: MW5071446
• Device Sequence Number: 1
• Product Code: MPO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/07/2017

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 Catalogue Number: 11460-010T
• Device Lot Number: MULTIPLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2017
• 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
• Patient Outcome(s): Required Intervention