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

Model Number	11450-040B
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1423537-2022-00821
• Device Sequence Number: 6476208
• Product Code: IMD
• UDI-Device Identifier: 10885380167188
• UDI-Public: 10885380167188
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/22/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female