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

Catalog Number	309605
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 10ml ll tip bulk convenience pak contained foreign matter.Verbatim: complaint via email.Email attached.Dmr # (b)(4) po #: (b)(4) defect material description: syringe tray, 10ml bd 20pk (ref.309605) lot number: 6078987 item code: 309605 defective quantity: 10 defect description: marking on the barrel of the 10 ml syringe, that seems like something chemically interacted with the plastic.2 samples available to be returned.Observed date: (b)(6) 2026 observed during which process stage: ilp ir/ dmi number if launched: sample availability for supplier to investigate: yes is defective evidence (i.E.Pictures; test results etc.) available? yes is patient impacted? no if defect has been reported to third party? no if the defect report from quva customer? no is there a trend observed? no supplier action investigation required.
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: 50479185
• Report Number: 1213809-2026-00445
• Device Sequence Number: 10396542
• Product Code: FMF
• UDI-Device Identifier: 30382903096054
• UDI-Public: (01)30382903096054
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 309605
• Device Lot Number: 6078987
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2026
• 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