MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; PACK, HOT OR COLD, DISPOSABLE

Model Number	11450-040
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
When hot pack was initiated, the contents burst out of package.

• Brand Name: CARDINAL HEALTH
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 9362355
• Report Number: 9362355
• Device Sequence Number: 2209799
• Product Code: IMD
• UDI-Device Identifier: 10885380167188
• UDI-Public: (01)10885380167188
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/01/2019
• Report Date (Section F): 11/01/2019

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: 11450-040
• Device Catalogue Number: 11450-040B
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/01/2019