MAUDE Adverse Event Report: MO016 MO-MOBERLY HOT PACK, SMALL, 4.5X9IN; PACK, HOT OR COLD, DISPOSABLE

Model Number	11443-512B
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Customer reported while starting to prep our patient, a visiting nurse from another floor who was shadowing me for iv insertion training and was opening a warm compress.She popped the hot pack, and it squirted all over my face, hair, upper and lower body.The white material crystalized on my body, and i had to go wash it off and change my scrubs.There were no injuries, and the product was discarded.
Additional Manufacturer Narrative
As no samples were returned for evaluation, a root cause could not be determined.Device history record review was completed on the reported lot v3b093.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.Cardinal health has made a business decision to close the site which manufactures product 11443-512b and transition to a third-party manufacturer.Cardinal health will continue to monitor and trend all reported product related issues for this product.

• Brand Name: HOT PACK, SMALL, 4.5X9IN
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• 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: 17675038
• Report Number: 1423537-2023-00986
• Device Sequence Number: 15081148
• Product Code: IMD
• UDI-Device Identifier: 10885380168406
• UDI-Public: 10885380168406
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/31/2023

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: 11443-512B
• Device Catalogue Number: 11443-512B
• Device Lot Number: V3B093
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/03/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown