MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS Luer-Lok; Syringe, Piston

Catalog Number	309628
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 1ml ll had leakage past the stopper.Verbatim: complaint via email.Email(s) attached.On 31mar2026 x was informed of an event with eylea 8mg vial kit which was categorized with the defect component issue, ci-dull injection needle on 31mar2026, x medical information was notified of an event: "the needle was too blunt additional information: for the reported observation of moisture behind the plunger, if this issue has already been reported to bd, please provide the corresponding reference number.Please provide reference numbers as this was not previously reported.If the issue has not been previously reported, kindly share the material number and batch/lot number of the syringe involved.309628 : 3324199 please confirm whether the syringe sample has already been returned to us.If not, kindly let us know if you require an additional shipping label for its return.Sample will be shipped later today.Shipping label has already been provided and it not required.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: Luer-Lok
• Common Device Name: Syringe, Piston
• 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: 25657704
• Report Number: 1213809-2026-00332
• Device Sequence Number: 9526621
• Product Code: FMF
• UDI-Device Identifier: 00382903096282
• UDI-Public: (01)00382903096282(17)281031(10)3324199
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K941562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2026

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: 309628
• Device Lot Number: 3324199
• 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: 06/10/2026
• Supplement Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 06/29/2026
• Supplement Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2023
• 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