MAUDE Adverse Event Report: CARDINAL HEALTH 200 LLC HOT PACK, MEDIUM, 6X6.5IN; PACK, HOT OR COLD, DISPOSABLE

Model Number 11450-040B

Device Problem Burst Container or Vessel (1074)

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

Event Date 07/17/2022

Event Type  malfunction  

Event Description

Nurse reported that while attempting to give patient a heat pack, she had one exploded on her.Only a little bit of the solution got on her skin, but it covered her jacket in the left chest and arm area.The actual packet was given to the charge nurse in a ziplocked bag, but not saved.No injury or other demographics provided.

Manufacturer Narrative

The device history review was completed on the reported lot number, v2e186.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.No sample was returned for investigation; therefore, a root cause could not be determined.Cardinal health will continue to monitor complaint trends.

• Brand Name: HOT PACK, MEDIUM, 6X6.5IN
• 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: 15272010
• MDR Text Key: 305008617
• Report Number: 1423537-2022-00821
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380167188
• UDI-Public: 10885380167188
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11450-040B
• Device Catalogue Number: 11450-040B
• Device Lot Number: V2E186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/17/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female