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

Catalog Number	309649
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
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 5ml ll euro 125 s/c had visible silicone.The following information was provided by the initial reporter: multiple sku w/ visible particles, defective plungers, excessive lubricant.When did the incident occur? before use.Please note that we have identified several quality defects in the syringes received under (b)(4).The issues observed include: visible particles inside the syringe, particles between the plunger and barrel space, multiple white particles found inside the packaging, defective plungers, excessive lubricant.The details of the rejected items can be found in the table below, and supporting photographs are attached for your reference.Ref no.Description size lot no qty received total qty received in pcs qty rejected % 309649, bd plastipak syringe, 5ml 4352949, 10box=1250 1250, 113 9.0%.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - silicone visible.A report was received indicating the presence of visible particles, defective plungers, and excessive lubricant.To support the investigation, one hundred fourteen samples of 5ml luer-lok syringes, two product packages, and two photographs were submitted for evaluation by the quality team.One of the packaging blisters contained a loose, red-colored foreign material, while the second blister exhibited a brownish substance within the packaging.No additional foreign matter was observed in the remaining samples.One photograph depicts a fully assembled syringe within its packaging, where the stopper is misaligned and improperly seated on the plunger rod, resulting in a distorted stopper.The second photograph shows the top web slip with the correct product information.The observed conditions are non-conforming with the product specifications.The distorted stopper is attributed to the assembly process, while the presence of loose foreign material is associated with the packaging process.A review of the device history record was conducted for material number 309649, lot 4352949.The review confirmed that all visual inspections were performed in accordance with established requirements, and no quality notifications were recorded related to the reported condition.The lot was inspected and accepted per the inspection control plan, approved for shipment, and deemed compliant with product specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 22789606
• Report Number: 1213809-2025-00531
• Device Sequence Number: 21287781
• Product Code: FMF
• UDI-Device Identifier: 00382903096497
• UDI-Public: (01)00382903096497(11)241217(17)291130(10)4352949
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/28/2025

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: 309649
• Device Lot Number: 4352949
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown