MAUDE Adverse Event Report: CARDINAL HEALTH 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	02/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Mw: (b)(4).Employee ¿cracked¿ the heel warmer, per instructions.The heel warmers contents exploded out of the top and landed on employee.This included the content getting into her right eye.The employee was seen by employee health and cleared to return to work.
Additional Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Additional Manufacturer Narrative
Supplemental report is being filed since the related report number (b)(4) was not originally included in the corresponding block h relate report number field of medical device report number 1423537-2024-00020 dated (06/01/2024).The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
Additional Manufacturer Narrative
Related medwatch report number 2100230000-2024-8004.Follow up report being filed since the investigation has been completed.Actual sample was not returned for investigation after multiple requests to the customer.Therefore, the root cause for crack in infant heel warmer could not be confirmed.A review of the device history record could not be performed as a lot number was not provided.Cardinal health will continue to monitor and trend all similar reported product related issues.
Additional Manufacturer Narrative
See related medwatch report number (b)(4) in h10.If additional information becomes available, a supplemental report will be submitted.

• Brand Name: INFANT HEEL WARMER SQUEEZE 4X4IN
• Common Device Name: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH; 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: 19442132
• Report Number: 1423537-2024-00020
• Device Sequence Number: 18199707
• Product Code: MPO
• UDI-Device Identifier: 10630140017391
• UDI-Public: 10630140017391
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/28/2024

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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 06/25/2024; 06/28/2024; 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2100230000-2024-8004
• Patient Sequence Number: 1
• Patient Sex: Female