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

Model Number 30104

Patient Problem Chemical Exposure (2570)

Event Date 08/10/2023

Event Type  malfunction  

Event Description

A patient care technician (pct) activated the hot pack and it began to leak on to their bare hands, the floor and clothing.No harm to pct.The pct activated a second hot pack and it also leaked.Both packs leaked along the seams of the pack but on different ends.

• Brand Name: CARDINAL HEALTH
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 17681998
• MDR Text Key: 322625454
• Report Number: 17681998
• 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: 08/14/2023

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: Other
• Device Model Number: 30104
• Device Catalogue Number: 30104
• Device Lot Number: VN23003-78
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/14/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1