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 12/01/2022

Event Type  malfunction  

Event 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.

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.

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.

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.

• 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: 16015106
• MDR Text Key: 307699259
• Report Number: 1423537-2022-00866
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 30104
• Device Catalogue Number: 30104
• Device Lot Number: V2J013
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 12/01/2022; 12/01/2022
• Supplement Dates FDA Received: 01/03/2023; 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female