MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT; SYRINGE, PISTON

Model Number	8881511110
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Covidien monoject 1ml insulin safety syringe found to have misprinted label on syringe.Printing was twisted around syringe.

• Brand Name: MONOJECT
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 23802102
• Report Number: 23802102
• Device Sequence Number: 7621730
• Product Code: FMF
• UDI-Device Identifier: 20884521014937
• UDI-Public: (01)20884521014937(17)280531(10)321932X
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2025
• Report Date (Section F): 12/03/2025

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
• Device Model Number: 8881511110
• Device Catalogue Number: 8881511110
• Device Lot Number: 321932X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/03/2025