MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTERLINK LUER-LOK; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	303348
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
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 10ml ll w/blunt plastic cann had foreign matter.The following information was provided by the initial reporter: material # 303348 lot # 5169511 verbatim: rcc received a complaint via community.Pir attached.When used to draw medication, black items will be in the medication syringe.¿ product code: 303348 patient/hcp impact: wasting of medications.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.One sample and one photo of a 10 ml luer lok tip syringe with a blunt plastic cannula were received for evaluation.Inspection identified an unknown blue tinged elastic foreign material within the syringes fluid path, and the photo provided confirmed the same condition.This finding is non conforming to product specifications, and the potential root cause of the foreign matter in fluid path defect is associated with the assembly process.A device history record review for material number 303348, lot 5169511, confirmed that all required in process and final inspections were completed with no quality notifications related to the reported condition.The lot met acceptance criteria, was approved for shipment, and complies with applicable product specifications.

• Brand Name: BD INTERLINK LUER-LOK
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 23798682
• Report Number: 1213809-2025-00770
• Device Sequence Number: 9288011
• Product Code: FMI
• UDI-Device Identifier: 00382903033485
• UDI-Public: (01)00382903033485(17)300531(10)5169511
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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: 303348
• Device Lot Number: 5169511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/13/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown