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

Model Number 30104

Device Problem Burst Container or Vessel (1074)

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

Event Date 11/23/2021

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 286920350
• Report Number: 1423537-2021-00702
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00630140039839
• UDI-Public: 00630140039839
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Model Number: 30104
• Device Catalogue Number: 30104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1