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	12/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported a leaking hot pack.Based on the follow up from the customer nurse reported when the hot pack was squeezed it leaked on her.The leakage touched the clinician on the top of her leg and on her lap.The clinician is fine with no reported issues after removing pack material by changing pants and by washing her skin.
Additional Manufacturer Narrative
This complaint was forwarded to the manufacturing facility where it is currently under investigation.A follow up report will be filed once the results have been completed.
Additional Manufacturer Narrative
Device history record review was completed on the reported lot v2j013.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.Visual inspection of the sample photo shows a small tear in the pouch, on the back near the bottom, however without a sample a root cause cannot be determined.Cardinal health will continue to monitor complaint trends.
Additional Manufacturer Narrative
Supplemental report is being filed since the sample has been received and the investigation results are available following the submission of the initial mdr report.One sample was received for evaluation that was already activated and had a tear in the pouch.The root cause of the leak was due to a torn pouch caused by the hypo bubble piercing the pouch.The machine was setup correctly and is designed with a mechanism which reduces the likelihood for this issue.All preventative maintenance was performed as assigned.Device history record review was completed on the reported lot v2j013.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.Cardinal health will continue to monitor complaint trends for this reported issue of leak and work to identify improvement activities to minimize reoccurrence.

• 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: 16015106
• Report Number: 1423537-2022-00866
• Device Sequence Number: 7426961
• Product Code: IMD
• UDI-Device Identifier: 00630140039839
• UDI-Public: 630140039839
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2023

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: 30104
• Device Catalogue Number: 30104
• Device Lot Number: V2J013
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 12/01/2022; 12/01/2022
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/03/2023; 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Female