MAUDE Adverse Event Report: CARDINAL HEALTH 200 LLC HOT PACK, LARGE, 6X9IN; PACK, HOT OR COLD, DISPOSABLE

Model Number 11443-012B

Device Problem Burst Container or Vessel (1074)

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

Event Date 08/03/2022

Event Type  malfunction  

Manufacturer Narrative

Device history review was not reviewed because the lot number was not available.A prepaid return label was sent to the customer to return the actual complaint sample for investigation.No sample was available at the time of investigation; therefore, the complaint could not be confirmed, and a root cause could not be determined.If the complaint sample is received later, the investigation will be re-opened.Cardinal health will continue to monitor complaint trends for this issue.

Event Description

Customer reported that when activating hot pack for iv placement, the hot pack exploded onto nurse¿s uniform, arm and onto the floor.The bag appeared to have a large cut or slice in it upon inspection.Nursing supervisor notified and environmental services (evs), into clean room.There were no injuries or lasting side effects.The substance from inside was washed off the 47-year-old female¿s arm with soap and water.

• Brand Name: HOT PACK, LARGE, 6X9IN
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200 LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: patricia tucker ; 3651 birchwood drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 15316463
• MDR Text Key: 305505643
• Report Number: 1423537-2022-00833
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380169267
• UDI-Public: 10885380169267
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2022

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: Health Professional
• Device Model Number: 11443-012B
• Device Catalogue Number: 11443-012B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female