MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number	309628
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 1ml ll had leakage.Verbatim: complaint via email.Email(s) attached.Please initiate a complaint investigation and have it completed within 45-60 days referencing x for ¿leaking syringe ¿.This is for syringe lots 5056026, 3034733.I am trying to confirm if photos or a complaint sample are available.Please include: record number: batch record review, manufacturing unplanned deviations, bulk retain sample inspection, analytic results, complaint history, root cause, confirmed or not confirmed.If issues may occur that may result in a delay in the report to exceed 45 days, please provide an interim status report.(b)(6) 2026: can you please provide an exact date of event in format dd-mmm-yyyy? (b)(6) 2026.What was the medication/fluid in use at the time of the event? izervay.When was this defect observed? during or before use? the leak occurred after the medication was withdrawn from the vial.Before administration to the patient.Was there a delay of, or change in, the course of treatment due to the event? yes, another kit had to be used by the hcp.Response receive on (b)(6) 2026: was there any visible cracks or damaged seen on syringe? the technician did not note any cracks or damage to the syringe.Where was syringe leaking? the technician stated that the leaking was observed when the needle connects to the syringe.Near the leur or barrel? by the luer lock.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD LUER-LOK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25201461
• Report Number: 1213809-2026-00259
• Device Sequence Number: 15961392
• Product Code: FMF
• UDI-Device Identifier: 00382903096282
• UDI-Public: (01)00382903096282(11)230315(17)280131(10)3034733
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K941562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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 Catalogue Number: 309628
• Device Lot Number: 3034733
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 05/18/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown