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

Model Number 11460-010T

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2019

Event Type  malfunction  

Event Description

Registered nurse (rn) attempted to pop infant heel warmer to place on patient's hand prior to iv insertion.Infant heel warmer broke open, contents landed on rn's hands and patient's mother's clothing.No harm to patient.

• Brand Name: CARDINAL HEALTH
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 808 w highway 24; moberly MO 65270
• MDR Report Key: 8623203
• MDR Text Key: 145498710
• Report Number: 8623203
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 05/07/2019

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 Model Number: 11460-010T
• Device Catalogue Number: 11460-010T
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/07/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2019
• Type of Device Usage: N
• Patient Sequence Number: 1