MAUDE Adverse Event Report: MO016 MO-MOBERLY INSULATED HOT PACK, LARGE, 6X9IN; PACK, HOT OR COLD, DISPOSABLE

Model Number	30104
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At the time of this investigation, the device history record could not be verified as a lot number was not provided.As no samples were returned for evaluation, a root cause could not be determined.We will continue to monitor complaint trends and utilize the information as part of continuous improvement.
Event or Problem Description
Customer reported that they received cardinal health hot packs that burst during transport while in the cardinal health totes.There was no injury reported and no one at the facility was exposed.
Additional Manufacturer Narrative
Supplemental report is being filed since samples from lot number v1l109 were returned for investigation.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.Ten samples were received for evaluation.Eight of the samples were not activated or leaking.One sample was pre-activated and one was pre-activated and torn.The root cause could be a torn pouch due to the bubble puncturing the pouch; it cannot be determined when the bubble punctured the pouch.Increased handling during shipping and processing are elements that could prompt pre-activation.We will continue to monitor complaint trends and utilize the information as part of continuous improvement.

• Brand Name: INSULATED HOT PACK, LARGE, 6X9IN
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer (Section G): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 13060521
• Report Number: 1423537-2021-00702
• Device Sequence Number: 19805243
• Product Code: IMD
• UDI-Device Identifier: 00630140039839
• UDI-Public: 00630140039839
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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: Other
• Device Model Number: 30104
• Device Catalogue Number: 30104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown