MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC - HOLDREGE, NE SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS; SYRINGE, PISTON

Model Number	328411
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: the investigation is currently in progress.Once the investigation is completed, a detailed summary will be provided.
Event or Problem Description
Fda report mw5178390 -foi.Event description- the patient had sq insulin lantus ordered for administration in the er.This medication is not stocked in our pyxis, so the medication was drawn up in pharmacy and given to me for administration.The needle from pharmacy is different from the ones we use in the er, so i didn't notice that the was not a safety mechanism (to cover sharps after adminstration) until after i gave the medication.After the patient was stuck, i recapped the needle (using recommended "sweep" method), then placed two fingers on either side of the needle cap to secure it on the syringe.The needle then poked through the side of the cap and into my finger.Lot # 2108035.Catalog# unknown - bd insulin syringe.Exp date 01-april 2027.Date of event 19-oct 2025.Date of medwatch report: 28-oct-2025.Date embecta received: 26-nov-2025.Sample status: n/a.Report attached to this case.Mw5178390.
Additional Manufacturer Narrative
Additional information was added to: b4, g6, h2, h11.Correction to: h6 (component code, type of investigation and investigation conclusions).Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): EMBECTA MEDICAL I LLC - HOLDREGE, NE
• Manufacturer Contact: anna garbowska-zakrzewski ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 23888556
• Report Number: 3024508819-2025-00298
• Device Sequence Number: 9464033
• Product Code: FMF
• UDI-Device Identifier: 00382908411035
• UDI-Public: 00382908411035
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K190054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 328411
• Device Lot Number: 2108035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Female