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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH 200 LLC INFANT HEEL WARMER,SQUEEZE, 4X4IN; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

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CARDINAL HEALTH 200 LLC INFANT HEEL WARMER,SQUEEZE, 4X4IN; INFANT HEEL WARMER (CHEMICAL HEAT PACK) Back to Search Results
Model Number 11460-010T
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2022
Event Type  malfunction  
Event Description
Customer reported upon activation, the infant heel warmer burst at the seams exposing hot gel contents onto the nurse¿s face and hands.Contents was washed off with water.There was no injury to the nurse.
 
Manufacturer Narrative
Device history review was completed on the reported lot number v2b110.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the record.No sample was returned for investigation, therefore, an evaluation of the complaint device for deficiency of construction could not be performed.We are unable to determine a specific assignable root cause for the reported incident.We will continue to monitor this failure mode for this product.
 
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Brand Name
INFANT HEEL WARMER,SQUEEZE, 4X4IN
Type of Device
INFANT HEEL WARMER (CHEMICAL HEAT PACK)
Manufacturer (Section D)
CARDINAL HEALTH 200 LLC
3651 birchwood dr
waukegan IL 60085
Manufacturer (Section G)
MO016 MO-MOBERLY
808 w highway 24
moberly MO 65270
Manufacturer Contact
patricia tucker
3651 birchwood drive
waukegan, IL 60085
8478874151
MDR Report Key14467485
MDR Text Key300347494
Report Number1423537-2022-00768
Device Sequence Number1
Product Code MPO
UDI-Device Identifier10630140017391
UDI-Public10630140017391
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/22/2022
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 Number11460-010T
Device Catalogue Number11460-010T
Device Lot NumberV2B110
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/27/2022
Initial Date FDA Received05/22/2022
Date Device Manufactured02/10/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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