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

Catalog Number	303310
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
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 20ml ll s/c 50 had foreign matter.The following information was provided by the initial reporter: material: 303310; batch#: 5132719.Verbatim: 2 different syringes had particulate in the syringe prior.The particles weren't present in the solution prior to use and was determined to be in the syringe.Images are attached but the 2 faulty items are still in the customer's office.
Event or Problem Description
Additional information from customer: describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No.In description mentioned "2 different syringes" both are listed with the same material number (#303310).If they are indeed different, please provide the material numbers for both.The syringes are the same.Was the syringe connected to a needle? if yes, was it a bd needle? if it was please share product information.Unknown needle type.What was used the syringe used for? if it was used to exact liquid from a vial, is it possible the needle caused coring? extract local anesthetic from vial.
Additional Manufacturer Narrative
Investigation results: two photos, twenty unused samples, and two used samples were received by our quality for evaluation.In the photos and used samples, a foreign material could be observed; therefore, the reported incident could be verified.However, the foreign material was sent for ftir analysis and the results obtained do not correlate with material used in our manufacturing process.A root cause could not be determined.A device history record review found no non-conformances associated with this issue during production of this batch.This incident has been added to our database of reported incidents.

• 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: 23953930
• Report Number: 9614033-2025-00127
• Device Sequence Number: 10595123
• Product Code: FMF
• UDI-Device Identifier: 00382903033102
• UDI-Public: (01)00382903033102(17)300531(10)5132719
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: 303310
• Device Lot Number: 5132719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 01/04/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown