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

Catalog Number	302995
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 10ml ll s/c contained foreign matter.Verbatim: complaint via email.Email(s) attached.On 3/11/2026, during compounding of lot 20260311-25595f, two syringes were discovered to have a deformed plunger.During visual inspection, one syringe was discovered to contain a foreign particulate, which appears to be a hair.The syringes were filled, and our process requires us to send out all filled units for testing, therefore they not available for return.Details for your investigation: product: 10 ml syringe.Lot number: 4354523.Part number: 302995.Number of defective units: 3.Defect type: syringe with deformed plunger.Syringe with foreign particulate.Product complaint: (b)(4).Quantity : (b)(4).
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) - supplemental mdr - foreign matter.Three photos of 10 ml luer lok syringes (part number 302995) were received and evaluated.The images show loose syringes containing an unknown yellow fluid; two photos indicate the stopper is jammed between the barrel and plunger rod, while the third shows a close up view with a hair like particulate present in the fluid path.The observed conditions are nonconforming to product specifications.The potential root causes of the distorted stopper and foreign matter defects are associated with the assembly process.A device history record review was completed for material number 302995, lot 4354523.All in process and final visual inspections were performed as required, and no quality notifications related to the reported condition were identified.The lot met acceptance criteria per the inspection control plan, was approved for shipment, and is in compliance with applicable product specifications.Complaints associated with this device and the reported condition will continue to be tracked and trended.Information will be captured in trend reports and monitored monthly, and the data will be regularly reviewed to identify any 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: 24778457
• Report Number: 1213809-2026-00165
• Device Sequence Number: 6132806
• Product Code: FMF
• UDI-Device Identifier: 00382903029952
• UDI-Public: (01)00382903029952(17)291130(10)4354523
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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: Other
• Device Catalogue Number: 302995
• Device Lot Number: 4354523
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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