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

Catalog Number	309628
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4)- supplemental mdr - foreign matter it was reported that foreign particles and plastic-like inclusions were recurring within bd 1 ml syringes.Thirteen photographs of 1 ml luer-lok syringes (part number 309628) were received and evaluated.The photographs show particulates of varying color, size, and location within the syringe barrels, including white or light-colored, brown or orange, and dark-colored particulates near the stopper and luer-end regions.The particulates appear distinct from the syringe components, stopper assemblies, and printed graduation markings, consistent with the presence of foreign matter.Additionally, three photographs show visible air bubbles within the syringe barrels near the luer end.The observed foreign matter and air bubbles are considered non-conforming per product specification, with the potential root cause associated with the assembly process.A review of the device history records (dhrs) was also completed for material number 309628, lots 3128967, 4285657, 5098930, 5121479, 5353614, and 5162348.All required visual inspections were performed, with no quality notifications identified related to the reported complaint defects.All batches met the applicable inspection control plan requirements, were accepted, and were subsequently approved for shipment.Complaints associated with this device and reported conditions will continue to be tracked and trended, with the data monitored monthly and routinely reviewed by the business team to identify any emerging trends.

• Brand Name: Luer-Lok
• Common Device Name: Syringe, Piston
• 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: 50169556
• Report Number: 1213809-2026-00405
• Device Sequence Number: 9886139
• Product Code: FMF
• UDI-Device Identifier: 00382903096282
• UDI-Public: (01)00382903096282
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K941562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: 309628
• Device Lot Number: 5353614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: 09/22/2026
• Initial Report FDA Received Date: 08/07/2026
• Supplement Report FDA Received Date: 09/29/2026
• 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