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

Catalog Number	309649
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
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 prior to use, it was recognized that bd syringe 5ml ll contained foreign matter.1x bd luer-lok syringe 5ml, lot 5072215, reason: contamination in the plastic at the bottom.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - foreign matter.Four samples of 5 ml eurographic syringes (part number 309649) were received in unsealed packages and evaluated, including two syringes from batch 4253037 and one each from batches 5072215 and 5072216.One syringe from batch 4253037 and one from batch 5072215 showed brown discoloration embedded in the barrel, while the second syringe from batch 4253037 exhibited major barrel and plunger rod damage.The syringe from batch 5072216 had significant barrel damage accompanied by black foreign matter in a non fluid path area.All observed conditions were non conforming to product specifications.The embedded foreign matter is most likely degraded plastic resulting from the molding process, where resin can be exposed to prolonged high temperatures inside the molding machine, particularly during start up; this embedded defect is cosmetic and does not pose a risk to the customer.The barrel damage, plunger rod damage, and non fluid path foreign matter are likely associated with the assembly process.A device history record review was completed for material number 309649, lots 4253037, 5072215, and 5072216.All in process and final visual inspections were performed as required, and no quality notifications related to the reported condition were identified.The lots met acceptance criteria per the inspection control plan, were approved for shipment, and were found to be in compliance with applicable product specifications.Complaints received for this device and reported condition will continue to be tracked and trended, with information captured on trend reports and monitored monthly.Our business team regularly reviews the collected data to identify emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: 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: 23888210
• Report Number: 1213809-2025-00795
• Device Sequence Number: 11929335
• Product Code: FMF
• UDI-Device Identifier: 00382903096497
• UDI-Public: (01)00382903096497(11)250313(17)300228(10)5072215
• 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): 03/03/2026

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: 309649
• Device Lot Number: 5072215
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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