MAUDE Adverse Event Report: MO016 MO-MOBERLY INFANT HEEL WARMER SQUEEZE 4X4IN; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number	11460-010T
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record review was completed on the reported lot v3a209.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.No samples were returned for investigation due to which a root cause could not be determined.Cardinal health will continue to monitor complaint trends for this reported issue of burst and work to identify improvement activities to minimize reoccurrence.
Event or Problem Description
Customer reported ¿the infant heel warmer popped recently, bursting on the nurse's intact skin of hands and on floor.There was no injury and the nurse is fine¿.

• Brand Name: INFANT HEEL WARMER SQUEEZE 4X4IN
• Common Device Name: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• 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 Key: 16587713
• Report Number: 1423537-2023-00888
• Device Sequence Number: 17676928
• Product Code: MPO
• UDI-Device Identifier: 10192253061420
• UDI-Public: 10192253061420
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: 11460-010T
• Device Catalogue Number: 11460-010T
• Device Lot Number: V3A209
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 03/21/2023
• Date Device Manufactured: 01/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female