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	06/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 1ml ll contained foreign matter.Complaint via email.X has received a product complaint related to an eylea 8mg vial kit.Kindly acknowledge receipt of this request and send us the complaint investigation reference number and due date when available.Complaint number: complaint description: catalog & lot number: investigational request /return component status: (b)(4).On (b)(6)2026 x was informed of an event with eylea 8mg vial kit which was categorized with the defect foreign matter fm - syringe.On (b)(6)2026, x was notified of an event: ¿it was a faulty syringe.The person drawing it up didn't notice it had a black mark on the inside of it¿.8542800023.Injection needle.Catalog: 309628.Lot: 3152795.Please perform an evaluation of their process to include the release inspection process and controls in place that would prevent deformed rubber stoppers.A sample is available and will be forwarded for further evaluation.Impact to patient: n/a.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• 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: 50445094
• Report Number: 1213809-2026-00440
• Device Sequence Number: 10281357
• Product Code: FMF
• UDI-Device Identifier: 00382903096282
• UDI-Public: (01)00382903096282(17)280531(10)3152795
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K941562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: 3152795
• 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: 08/05/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/13/2023
• 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