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

Model Number	V11450-040B
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• 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 drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 18576953
• Report Number: 1423537-2024-00007
• Device Sequence Number: 8926000
• Product Code: IMD
• UDI-Device Identifier: 10885380167195
• UDI-Public: 10885380167195
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2024

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: V11450-040B
• Device Catalogue Number: V11450-040B
• Device Lot Number: V2L284
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 01/24/2024
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male