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

Model Number	V11450-040B
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reported by registered nurse that as he squeezed the "novaplus hot pack instant" to activate it, the contents squeezed out the top.

• Brand Name: NOVAPLUS
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 19095969
• Report Number: 19095969
• Device Sequence Number: 7705395
• Product Code: IMD
• UDI-Device Identifier: 10192253061406
• UDI-Public: (01)10192253061406
• 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): 01/09/2024
• Report Date (Section F): 01/09/2024

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: V11450-040B
• Device Catalogue Number: V11450-040B
• Device Lot Number: V2L284
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/09/2024