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

Catalog Number	309649
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
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 the bd syringe 5ml ll euro 125 s/c had foreign matter.The following information was provided by the initial reporter: it was reported that silicone droplets in syringe.After the patient has received heavy water in the eye, a bubble is seen in the syringe.It is not air but looks like silicone oil.The syringe is kept, and a random identical syringe is unpacked together with chief physician (b)(6); ia droplet is clearly visible on the black membrane.During use: the incidence has caused no harm to patients.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - foreign matter.Ten samples and one photo of 5 ml eurographic syringes (part number 309649, batch 5181790) were received for evaluation.All samples arrived in sealed packages with complete product information, and no defects were observed on any of the syringes.Silicone was visible on the stoppers; however, it was neither pooling nor stringing and is acceptable per product specifications.The photo showed a loose syringe with the same normal silicone appearance.Silicone is an inert, non toxic medical lubricant essential to syringe function and does not pose any safety or performance concerns.It has been safely used in this application for more than 25 years, with distribution exceeding 30 billion units and no known adverse clinical effects associated with unintentional silicone delivery.Please refer to the attached silicone quantity guideline for reference.A device history record review was completed for material number 309649, lot 5181790.All in process and final visual inspections were performed as required, and no quality notifications related to the reported condition were identified.The lot met acceptance criteria per the inspection control plan, was approved for shipment, and complies with applicable product specifications.Complaints received for this device and the reported condition will continue to be tracked and trended, with information documented in monthly trend reports.Our business team regularly reviews collected data to identify any emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: 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: 23953899
• Report Number: 1213809-2025-00804
• Device Sequence Number: 16132305
• Product Code: FMF
• UDI-Device Identifier: 00382903096497
• UDI-Public: (01)00382903096497(11)250630(17)300630(10)5181790
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 03/03/2026

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: 309649
• Device Lot Number: 5181790
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 01/04/2026
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown