MAUDE Adverse Event Report: MO016 MO-MOBERLY NOVAPLUS HOT PACK, LARGE, 6X9; PACK, HOT OR COLD, DISPOSABLE

Model Number	V11443-012B
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We received four samples that were already activated.One sample has no apparent defect.Three samples appear to have been cut with a sharp instrument and the failure cannot be confirmed.The exact root cause cannot be determined since the origin of the cut in the pouch is unknown.Device history record was completed on the reported lot v2p178.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.The product shipper does indicate ¿do not use a sharp knife¿ when opening the case to avoid any damage to the product.Cardinal health will continue to monitor complaint trends for this reported issue.
Event or Problem Description
Complaint received on medwatch report, (b)(4).Customer reported that when a patient needed a hot pack for an iv start, the rn went to activate it by squeezing and it burst.There was no injury to the patient.The gel landed on the team members skin without any injury.

• Brand Name: NOVAPLUS HOT PACK, LARGE, 6X9
• 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: 16649716
• Report Number: 1423537-2023-00895
• Device Sequence Number: 6097561
• Product Code: IMD
• UDI-Device Identifier: 10885380167218
• UDI-Public: 10885380167218
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2023

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: V11443-012B
• Device Catalogue Number: V11443-012B
• Device Lot Number: V2P178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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: Unknown