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

Catalog Number	309658
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
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 3ml ll euro 200 s/c had a syringe needle connectivity issue.Verbatim: when drawing the medication into the syringe, the connection point between the syringe and needle leaks.Unfortunately, the needle in question has not been sent for complaint, only the syringe.Customer said that the event day is the day the product complaint has submitted.No harm for patient or nurse.Customer doesnt know, what kind of liquid and medicine was involved, but those were ordinary.No toxic were use.Maybe propofoli.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation the junction between the syringe and needle was reported as defective.To support the investigation, our quality team received one sample 3ml eurographic syringe from lot 5245399 for evaluation.The syringe was received in unsealed packaging, with all applicable product information present on the top web.No needle was included with the returned sample.Upon examination, no defects were observed on the syringe.In addition, a bd needle was properly attached to the syringe, and a leak test was performed, no leakage was observed.The returned syringe sample is acceptable and meets product specifications.A device history record review was completed for material number 309658, lot 5245399.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 inspection control plan, approved for shipment, and is considered compliant with product specification requirements.Based on the investigation and evaluation of the returned sample, the condition reported by the customer could not be 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: 24563579
• Report Number: 1213809-2026-00110
• Device Sequence Number: 21192302
• Product Code: FMF
• UDI-Device Identifier: 00382903096589
• UDI-Public: (01)00382903096589
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 309658
• Device Lot Number: 5245399
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2025
• 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