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

Model Number V11443-012B

Device Problem Burst Container or Vessel (1074)

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

Event Date 02/22/2023

Event Type  malfunction  

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 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
• 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: 16649716
• MDR Text Key: 312677071
• Report Number: 1423537-2023-00895
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380167218
• UDI-Public: 10885380167218
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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