MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC MONOJECT; SYRINGE, PISTON

Model Number	8881892950
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the nursing floor has had accidental needlestick incidents involving syringe model 8881892950, all dispensed by pharmacy for long-acting insulin administration.The core safety concern is that the needle guard on this syringe does not engage smoothly.Initially, it slides up and appears to stop, which can give the impression that the needle is fully covered.However, nurses need to apply additional force beyond this initial resistance to fully activate the safety guard and properly cover the needle.This incomplete closure creates a risk for accidental needlesticks.Additional information received on 24jul2025 stated that the nurses had to draw additional exposure protocol lab work for each patient that the needle stick occurred with as they were all contaminated accidental needle sticks (i.E.Post injection with the patient).First aid was applied to all.There was emotional distress and paperwork for all encounters.On 29jul2025 it was confirmed that the nurses did not require lab work or medication.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Without a known lot number, the device history record cannot be reviewed.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.One photo was provided for evaluation; however, we could not observe any issues with the safety shield not functioning as intended when analyzing the photograph.There were no physical devices returned for evaluation; therefore, the affected product could not be evaluated to confirm the reported failure.As such, a root cause could not be determined.No corrective actions are needed at this time.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: MONOJECT
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 22743839
• Report Number: 1423537-2025-00311
• Device Sequence Number: 12583584
• Product Code: FMF
• UDI-Device Identifier: 10192253025538
• UDI-Public: 10192253025538
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K061492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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: 8881892950
• Device Catalogue Number: 8881892950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/15/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown