MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC; HEEL WARMER, INFANT

Device Problems Burst Container or Vessel (1074); Chemical Spillage (2894)

Patient Problem No Code Available (3191)

Event Date 07/16/2015

Event Type  malfunction  

Event Description

Rn was using the cardinal health infant heel warmer.She broke the packet to activate it and it exploded.The liquid spilled all over the floor and the rn's gloves.The rn was not near any infants.Because the rn wore gloves, she did not sustain any superficial burns.

• Type of Device: HEEL WARMER, INFANT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 1500 waukegan road; waukegan IL 60085
• MDR Report Key: 5009892
• MDR Text Key: 23243598
• Report Number: 5009892
• 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: User Facility
• Reporter Occupation: Other
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/04/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1