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

Model Number 11460-010T

Device Problem Gel Leak (1267)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2022

Event Type  Injury  

Event Description

Before checking the baby's blood sugar the heel warmer popped open and contents splattered on sink and accucheck machine.Fda safety report id# (b)(4).

• Brand Name: CARDINAL INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 15067026
• MDR Text Key: 296312767
• Report Number: MW5110973
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/15/2022

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
• Device Lot Number: V2C235
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention