MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD LUER-LOK; PISTON SYRINGE

Catalog Number	309657
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
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 bd syringe 3 ml ll 200 s/c contained foreign matter.Verbatim: rcc received a complaint via email.Email(s) attached.Not sure where to send this.One of the syringes we ordered for our xxx had some particulates inside.Is there any way to report this to xx? what is the process for that? ref 309657, lot 5048672, exp 2030-02-28.03/02/2026: only a single vial of lot 84036 was seen to be affected.The vial is saved and bagged.It is currently hanging on the whiteboard at the (b)(6) clinic.As of now, no harm or negative outcome has come of pt mrn (b)(6).Patient is scheduled to return on (b)(6) 2026.
Additional Manufacturer Narrative
Investigation results: three photos were received by our quality team for evaluation.The photos show the presence of white particles in liquid inside the syringe; however, without a physical sample, verification of what the white particles are cannot be completed.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, a root cause could not be determined without the ability to perform the appropriate analysis to identify the nature and origin of the particles.This incident has been added to our database of reported incidents.
Event or Problem Description
No additional information.

• Brand Name: BD LUER-LOK
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24650255
• Report Number: 9614033-2026-00020
• Device Sequence Number: 15892896
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: (01)30382903096573(10)5048672
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 04/23/2026

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: 309657
• Device Lot Number: 5048672
• 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: 03/03/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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