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	Discomfort (2330)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Night shift nicu rn opened an infant heel warmer and it did not activate.The powder came out through the top and got in the rn's eye.Shift supervisor was notified and called poison control for instruction on exposure.Rn flushed eye at time of contact and used artificial tears for treatment.Rn having no pain or further complications.
Additional Manufacturer Narrative
A sample was received for evaluation and the investigation determined that the sample received was already activated but the defect reported was unconfirmed.The root cause could not be determined as the sample had no apparent defects and was not found to be leaking.Device history record review was completed on the reported lot, and the lot was manufactured and released in compliance with all requirements.No anomalies were found during review of the records.Cardinal health will continue to monitor complaint trends for this reported issue of burst and work to identify improvement activities to minimize reoccurrence.

• 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: 16287435
• Report Number: 1423537-2023-00876
• Device Sequence Number: 4757968
• Product Code: MPO
• UDI-Device Identifier: 10630140017391
• UDI-Public: 10630140017391
• 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: Other,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/02/2023

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: V2P263C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 82 KG