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	01/01/1980
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported that a cardinal health heel warmer burst while being activated by a nurse, landing in her eye.Pain and redness of rn¿s eye was noted, the eye was flushed with saline, and no other medication was provided.The pack material was removed by cold water in the sink.The nurse reported no issues after the incident.
Additional Manufacturer Narrative
No samples were returned by the customer and therefore we are unable to confirm the root cause for the issue reported.Device history record review was completed on the reported lot v2s065.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.Cardinal health will continue to monitor and trend all reported product related issues for this product.

• 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 dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 17328020
• Report Number: 1423537-2023-00960
• Device Sequence Number: 15044467
• Product Code: MPO
• UDI-Device Identifier: 10630140017391
• UDI-Public: 10630140017391
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2023

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: V2S065
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2022
• 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 Age: 36 YR
• Patient Sex: Female
• Patient Weight: 70 KG