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

Model Number V11450-040B

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem Chemical Exposure (2570)

Event Date 01/03/2023

Event Type  malfunction  

Event Description

On two separate occasions, the instant hot pack (6 in.X 6.5 in) broke and the chemicals inside spilled out and onto patients.One patient ([redacted] old male) popped the hot pack himself, and the chemicals leaked on his shirt and hands.Patient encouraged to wash his hands, and he was provided a new shirt.The second instance occurred when a care assistant popped the hot pack and provided it to a patient.The hot pack had a hole in the package, which was not noticed until the chemicals spilt onto the patient's hands.The patient was encouraged to wash his hands.No harm was noted on either patient.These two products were removed from use.

• 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: 16303159
• MDR Text Key: 308836372
• Report Number: 16303159
• Device Sequence Number: 1
• Product Code: IMD
• 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: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: V11450-040B
• Device Catalogue Number: V11450-040B
• Device Lot Number: V2J079
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6935 DA
• Patient Sex: Male
• Patient Weight: 68 KG