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

Catalog Number	303310
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
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 bd syringe 20ml ll s/c 50 contained foreign matter.Bd 20 ml syringe luer-lock tip syringe with small plastic piece inside.Pharmacy technician identified plastic remnant in bd 20ml luer-lock tip syringe.
Additional Manufacturer Narrative
Investigation results: one sample was received by our quality team for evaluation.Photos were taken of the sample, and it was then forwarded for further analysis.Unfortunately, it was obtained by customs, and we could not retrieve it.Please understand this is a rare occurrence and we apologize.Based on the photos taken of the sample, the reported defect could be verified since material was seen in the fluid path of the syringe.However, since we no longer have the physical sample, testing on the material cannot be completed.A walk through of the manufacturing line was still completed to identify potential sources of contamination.A potential source of the material could be plastic from the manufacturing process.Improvements have been made because of this report.A review of the internal manufacturing device records for the reported lot number was performed and no recorded quality problems or rejections related to this incident were found.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: 23977766
• Report Number: 9614033-2025-00129
• Device Sequence Number: 19971759
• Product Code: FMF
• UDI-Device Identifier: 00382903033102
• UDI-Public: (01)00382903033102(10)5163348
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: 5163348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2025
• 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