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

Catalog Number	309646
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd syringe 5ml ll had leakage.Incident or problem information 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 - reached the patient/person - inconvenient optional report to: yes.Incident details: when pushing rocuronium, the drug leaked out of the side of the syringe.Device information device name/description: syringe luer lock tip 5ml.Manufacturer manufacturer code/model: 309646 serial or lot number: (b)(6) expiry date: 2030-11-30.Supplier: supplier/catalogue number: 308-309646 is the device retained? yes number of devices: 2 wiped, contained, labelled? wiped, doubled bagged (if consumable), and labelled as per instructions.Investigation request expected type of investigation: actual device tested; lot review ¿ are you noticing a trend with cracks/leaking from the syringe where the medication rocuronium is identified? e-mail address for person holding device: site shipping address: clinical contact information.Primary clinical contact (cc on final report): manager (cc on final report): filing reference id: (b)(4).

• 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: 25128085
• Report Number: 1213809-2026-00247
• Device Sequence Number: 15646269
• Product Code: FMF
• UDI-Device Identifier: 30382903096467
• UDI-Public: (01)30382903096467(11)251215(17)301130(10)5349997
• 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): 05/29/2026

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: 309646
• Device Lot Number: 5349997
• 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: 04/22/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2025
• 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