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

Model Number 11443-012B

Device Problem Material Rupture (1546)

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

Event Date 05/12/2022

Event Type  malfunction  

Event Description

Registered nurse (rn) attempted to activate a cardinal health instant hot pack bag, and the package burst at top in a vertical fashion.Based on the appearance of the bag, the user may have applied pressure at the base and not at the squeeze line in the middle as instructed on the bag.No contents of the bag were spilled onto the rn, and the patient was not in the same room during the attempt to activate the bag.No harm.

• 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: 14986165
• MDR Text Key: 295688704
• Report Number: 14986165
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• 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: V2C230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2022
• Date Report to Manufacturer: 07/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1