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

Catalog Number	302995
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 10ml ll s/c 200 stopper separation from plunger.Verbatim: complaint via email.Email(s) attached.Reference number (id): (b)(4).Date of incident (yyyy-mm-dd): (b)(6)2026.Type of incident/problem: a2.Failure (i.E.While preparing for, in use, after use).Level of harm: no apparent harm.Alberta optional report to cmdsnet (health canada): yes.Incident details: while drawing blood cultures off arterial line with 10 ml syringe, black seal noted to have separated from plunger resulting in blood spillage procedure: blood draw.Device information device name/description: syringe luer lock tip 10ml.Manufacturer code/model: 302995.Serial or lot number: (b)(6).Expiry date: 2030-12-31.Supplier/catalogue number: 308-302995.Is the device retained? yes.Number of devices: 1.I apologize for the miscommunication, but the device was not retained due to gross blood contamination.It was initially retained by the rn, and discarded after the rls was filed.
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 ; +1(847)393-5694
• MDR Report Key: 50842489
• Report Number: 1213809-2026-00493
• Device Sequence Number: 10301468
• Product Code: FMF
• UDI-Device Identifier: 00382903029952
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 302995
• Device Lot Number: 6012718
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2026
• 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