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

Model Number V11450-040B

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2024

Event Type  malfunction  

Event 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
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 19095969
• MDR Text Key: 340019925
• Report Number: 19095969
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10192253061406
• UDI-Public: (01)10192253061406
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 01/09/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1