MAUDE Adverse Event Report: CARDINAL HEALTH 200 LLC HOT PACK, MEDIUM, 6X6.5IN; PACK, HOT OR COLD, DISPOSABLE

Model Number	11450-040B
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported through medwatch report- mw5111362.A healthcare worker reported that while a patient was activating a hot pack it burst open and spilled contents onto the patient's bed.Patient states she was not burned but a sand-like substance got on her bed.Patient was unharmed.
Additional Manufacturer Narrative
Device history review was completed on the reported lot v2e179.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 due to which a root cause could not be determined.We will continue to monitor for complaint trends.A cross-functional team has been established by cardinal health to closely monitor burst complaints.

• Brand Name: HOT PACK, MEDIUM, 6X6.5IN
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200 LLC; 3651 birchwood dr.; waukegan IL 60085
• 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: 15440823
• Report Number: 1423537-2022-00840
• Device Sequence Number: 5672870
• Product Code: IMD
• UDI-Device Identifier: 10885380167188
• UDI-Public: 10885380167188
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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: Lay User/Patient
• Device Model Number: 11450-040B
• Device Catalogue Number: 11450-040B
• Device Lot Number: V2E179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/16/2022
• Date Device Manufactured: 05/17/2022
• 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: 32 YR
• Patient Sex: Female