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

Catalog Number	309657
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 3ml ll 200 s/c contained foreign matter.Verbatim: complaint via email.On 14jul2026, during manufacturing a small, black free floating particulate was identified in the product.The particulate was sent out to a third party for identification which determined that it was polypropylene with silicone (see attached).After review of all the components used in the manufacturing process up to the point where the particulate was found, determined that several different syringes were used in the process (see below) which are comprised of polypropylene and silicone.X would like to request an investigation into these three lots of syringes to determine if there were any issues during manufacturing, along with controls in place to prevent particulate contamination of the syringes specifically polypropylene and/or silicone.Please let me know if there are any questions regards: nvs sap material: 5004641.Nvs sap batch: mp0018.Vendor: 50085232 / becton dickinson.Vendor material #: 309657.Vendor batch: 4285707.Expiry: 30sep2029.Po # (b)(4).
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• 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 ; +1(847)393-5694
• MDR Report Key: 50899354
• Report Number: 1213809-2026-00502
• Device Sequence Number: 18817852
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: (01)30382903096573
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: 309657
• Device Lot Number: 4285707
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2024
• 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