MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number	300912
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.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 eurographics had foreign matter.The following information was provided by the initial reporter: a medication was to be administered to a patient.However, contamination was found on the syringe plunger before use.Therefore, this syringe was not used but was kept as a sample and kindly made available to us.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.Contamination was reported on the inner portion of the syringe plunger.To support the investigation, one sample of a 10 ml eurographics syringe from lot 4347922 was submitted to the quality team for evaluation.The sample was received in unsealed packaging that included all relevant product information.Upon inspection, the plunger rod exhibited multiple black discoloration marks consistent with embedded foreign material.This condition is non-conforming per product specifications and is attributed to the molding process.Specifically, the presence of degraded resin embedded in the component typically results from prolonged exposure to high temperatures within the molding machine, such as during equipment start-up.This type of defect is considered cosmetic in nature and does not pose a risk to the end user.A device history record (dhr) review was conducted for material number 300912, lot 4347922.The review confirmed that all visual inspections were performed in accordance with established requirements, with no quality notifications related to the reported condition.The lot was inspected and accepted per the inspection control plan, approved for shipment, and deemed compliant with applicable product specifications.

• 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 ; 8473935694
• MDR Report Key: 22865659
• Report Number: 1213809-2025-00565
• Device Sequence Number: 15366292
• Product Code: FMF
• UDI-Device Identifier: 00382903009121
• UDI-Public: (01)00382903009121(11)241212(17)291130(10)4347922
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2025

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: 300912
• Device Lot Number: 4347922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown