MAUDE Adverse Event Report: CARDINAL HEALTH CARDINAL HEALTH; INFANT HEEL WARMER INSTANT SQUEEZE

Model Number 11460-010T

Device Problems Burst Container or Vessel (1074); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Issues with infant heel warmers with instant squeeze activation.Multiple warmers upon squeezing, burst open with warm gel squirting out.Potential for harm to personnel using as well as patients.

• Brand Name: CARDINAL HEALTH
• Type of Device: INFANT HEEL WARMER INSTANT SQUEEZE
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 6303573
• MDR Text Key: 66740569
• Report Number: MW5067674
• Device Sequence Number: 1
• Product Code: MPO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11460-010T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• 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