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

Catalog Number	309575
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 3ml ll w/ndl 21x1 rb had leakage past the stopper.Verbatim: complaint via email.Earlier today, one of my dispensers noticed that their syringe was leaking down the plunger and had leaked through the rubber stopper piece.I have attached the images.It is little difficult to tell as the dispensers must use a syringe shield, but the liquid is faintly visible within the shield.Can you please provide an exact date of event in format dd-mmm-yyyy: 10-mar-2026.Can you please provide the material and lot number associated with reported issue: material number - 309575, lot # - 5241754.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label: no, the defect was found on the syringe while filling a dose.- the syringe is contaminated.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event: slowed down production.
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: 24776490
• Report Number: 1213809-2026-00174
• Device Sequence Number: 15949456
• Product Code: FMF
• UDI-Device Identifier: 30382903095750
• UDI-Public: (01)30382903095750(10)5241754
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: Other
• Device Catalogue Number: 309575
• Device Lot Number: 5241754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2025
• 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