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	09/09/2025
Type of Reportable Event	Malfunction
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: on b)(6) 2025, a particle is observed in the 10 ml syringe.The defect item is not available.However, the picture showing the defect is provided in the attachment to support investigation.A root cause within novartis can be nearly be excluded.We kindly ask you to investigate the root cause and send your investigation report.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) follow up three photos of a 10ml ll eurographics syringe (part number 300912), batch 3178432, were reviewed, showing syringes with brownish discoloration on the barrel tip.This condition is non-conforming to product specifications.A molding engineer confirmed the defect is likely caused by burning during the molding process, resulting from degraded plastic due to prolonged high temperatures, typically during machine start-up.While procedures require scrapping parts until no degraded material remains, incomplete execution can allow such defects to pass.The issue is cosmetic only and poses no risk to customers, with the root cause linked to the molding process.Additionally, a device history record review was completed for lot number 3178432, which showed no rejected inspections or quality issues during production that could have contributed to the reported defect.

• 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: 23577150
• Report Number: 1213809-2025-00721
• Device Sequence Number: 15802147
• Product Code: FMF
• UDI-Device Identifier: 00382903009121
• UDI-Public: (01)00382903009121(11)230627(17)280531(10)3178432
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: Other
• Device Catalogue Number: 300912
• Device Lot Number: 3178432
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown