MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC 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	10/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record was reviewed for the reported lot number: v2c235d.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; therefore, a root cause could not be determined.The manufacturing site will continue to monitor complaint trends.
Event or Problem Description
Customer reported, we are having issues with the heel warmers busting and the contents got into the patient's caregiver eye.No medication was given, but the caregiver eyes were flushed.I would like to report it as a product failure.No demographics or additional information provided.
Additional Manufacturer Narrative
Supplemental report is being filed following the submission of the initial mdr report submitted on 11/22/2022 since samples were returned for investigation.Device history record was reviewed for the reported lot number, v2c235d.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.Six activated samples were returned for investigation and displayed a top seal leak.The exact root cause for burst was not determined.The manufacturing site will continue to monitor complaint trends.

• Brand Name: INFANT HEEL WARMER,SQUEEZE, 4X4IN
• Common Device Name: 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 Key: 15843465
• Report Number: 1423537-2022-00863
• Device Sequence Number: 6901873
• Product Code: MPO
• UDI-Device Identifier: 10630140017391
• UDI-Public: 10630140017391
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 04/23/2023

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: V2C235D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 04/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown