MAUDE Adverse Event Report: MO016 MO-MOBERLY NOVAPLUS HOT PACK MEDIUM 6X6.5 INCH; PACK, HOT OR COLD, DISPOSABLE

Model Number V11450-040B

Device Problem Burst Container or Vessel (1074)

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

Event Date 01/01/1980

Event Type  malfunction  

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.

Event Description

Customer stated, we have recently received concerns from our phlebotomy team regarding ruptured hot packs.They have confirmed product to be cardinal¿s and have provided one lot number so far.Three staff members were splashed and had to wash off their clothes, no harm just discomfort.

Manufacturer Narrative

As no samples were returned for evaluation, a root cause could not be determined.The device history record review was completed on the reported lot v2l284, and the lot was manufactured and released in compliance with all requirements.Cardinal health will continue to monitor complaint trends for this reported issue.

• Brand Name: NOVAPLUS HOT PACK MEDIUM 6X6.5 INCH
• 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 drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 18576953
• MDR Text Key: 334257391
• Report Number: 1423537-2024-00007
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380167195
• UDI-Public: 10885380167195
• 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
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V11450-040B
• Device Catalogue Number: V11450-040B
• Device Lot Number: V2L284
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: No
• 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: Male