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

Catalog Number 11470-010T

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 04/13/2015

Event Type  malfunction  

Event Description

A heel warmer was placed on the infant's foot.The father was gently massaging the foot while the patient care tech (pct) was outside of the room.When the pct re-entered the room, the father showed the tech where the heel warmer leaked.The pct came to get the supervisor of the department to show her what happened.Per the father, the liquid did not get on the infant's foot, it only got on the infant's pant leg.The parent removed the pants.Upon examination of the infant's foot, there was no indication the liquid spilled on the foot.

• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 808 west highway 24; moberly MO 65270
• MDR Report Key: 4686848
• MDR Text Key: 16851811
• Report Number: 4686848
• Device Sequence Number: 1
• Product Code: MPO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/13/2015

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 Catalogue Number: 11470-010T
• Device Lot Number: C020315
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/13/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/13/2015
• Patient Sequence Number: 1