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

Model Number 11443-012B

Device Problem Burst Container or Vessel (1074)

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

It has been reported that a hot pack burst while opening.There was no additional information provided from user.

Manufacturer Narrative

Five samples were received for evaluation.No anomalies were found during sample investigation.The sample(s) had no issues and were activated in the lab.Device history review was completed on the reported lot v3c216.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.The root cause was determined to be unconfirmed.Cardinal health has made a business decision to close the site which manufactures product and transition to a third-party manufacturer.Cardinal health will continue to monitor and trend all reported product related issues.

• Brand Name: 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 birchhwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 17966414
• MDR Text Key: 326059203
• Report Number: 1423537-2023-00999
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380169267
• UDI-Public: 10885380169267
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11443-012B
• Device Catalogue Number: 11443-012B
• Device Lot Number: V3C216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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