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

Lot Number V8C355

Device Problem Burst Container or Vessel (1074)

Patient Problem No Information (3190)

Event Date 06/15/2018

Event Type  malfunction  

Event Description

One end of the hot pack package opened explosively when pressure was applied per the package instructions.

• Brand Name: CARDINAL HEALTH
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 808 w highway 24; moberly MO 65270
• MDR Report Key: 7705964
• MDR Text Key: 114606923
• Report Number: 7705964
• 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: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: V8C355
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2018
• Date Report to Manufacturer: 07/20/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11680 DA