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

Model Number V11443-012B

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 09/25/2021

Event Type  malfunction  

Event Description

Customer requested instant hot pack.The hot pack popped when squeezed, but the hot pack remained cold.The same scenario occurred with three packs.Even after a couple of hours went by the packs did not get warm and did not stiffen as it cooled.All hot packs had the same lot number.

• Brand Name: NOVAPLUS HOT PACK INSTANT
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 12568060
• MDR Text Key: 274529147
• Report Number: 12568060
• 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: 09/30/2021,09/27/2021

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: No Information
• Device Model Number: V11443-012B
• Device Catalogue Number: V11443-012B
• Device Lot Number: VK140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/04/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1