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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 04/28/2022
Event Type  malfunction  
Manufacturer Narrative
Device history record review was completed on the reported lot number v2c104.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.One sample was received for investigation and was already activated.The sample was inspected for any damage or defects; no issues were identified.Therefore, the reported event could not be confirmed.Cardinal health will continue to monitor complaint trends for this issue.
 
Event Description
Customer reported an infant heel warmer was leaking from the side seal after activation.There was exposure but fortunately, the lab tech was wearing gloves.No injury reported.
 
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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 drive
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 Key14493929
MDR Text Key300446873
Report Number1423537-2022-00771
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
Reporter Occupation Other
Type of Report Initial
Report Date 05/24/2022
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 NumberV2C104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2022
Initial Date Manufacturer Received 04/28/2022
Initial Date FDA Received05/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/10/2022
Is the Device Single Use? Yes
Type of Device Usage A
Patient Sequence Number1
Patient SexFemale
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