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

Model Number 11443-012B

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

Event Date 01/16/2024

Event Type  malfunction  

Event Description

Upon applying pressure to this bag to crack it to activate it, the pack exploded on registered nurse.

• 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: 18796342
• MDR Text Key: 336410528
• Report Number: 18796342
• 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: 01/31/2024

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 Model Number: 11443-012B
• Device Catalogue Number: 11443-012B
• Device Lot Number: VN23291-78
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2024
• Date Report to Manufacturer: 02/28/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/28/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1