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

Catalog Number	309695
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd 309695 - syringe control 10ml ll barrel cracked.Verbatim: rcc received a complaint via email.Incident or problem information: mdip 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.(b)(6) optional report to cmdsnet (health canada): incident details: surgeon was injecting local anesthetic using the 10cc control top syringe.The syringe cracked while she was injecting and local sprayed out.Who was affected? no person affected.Frequency of problem: first time.Invasive procedure? yes.Procedure: dilation and curettage.Device information: device name/description: syringe luer lock tip finger control 10ml.Manufacturer: becton dickinson canada inc.Manufacturer code/model: 309695.Serial or lot number: (b)(4).Expiry date: 2030-08-31.Supplier: medline canada corporation: supplier/catalogue number: 308-309695.Is the device retained? yes.Investigation request: expected type of investigation: actual device tested; lot review.(b)(6).
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation it was reported that the syringe cracked during injection and that local anesthetic sprayed from the device.To support the investigation, one 10 ml luer lok syringe from lot 5255212 was returned and evaluated by the quality team.The sample was received fully assembled and loose.Upon inspection, a significant crack was observed on the barrel, extending from near the top of the barrel to approximately the 10ml mark, located in the non scale marking area.This condition is nonconforming to the product specification and is considered to be associated with the assembly process.A device history record review was completed for material number 309695, lot 5255212.The review confirmed that all required visual inspections were performed in accordance with established requirements, and no quality notifications were identified related to the reported condition.The lot was inspected and accepted per the approved inspection control plan, released for shipment, and is considered compliant with applicable product specification requirements.To date, no additional similar events have been reported for this lot.Based on the investigation and analysis of the returned sample, the customer reported symptom is confirmed.

• 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: 24619134
• Report Number: 1213809-2026-00127
• Device Sequence Number: 9575901
• Product Code: FMF
• UDI-Device Identifier: 00382903096954
• UDI-Public: (01)00382903096954
• 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): 05/05/2026

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: 309695
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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