MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL LUER-LOK; SYRINGE, PISTON

Catalog Number	302832
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, syringe 30ml ll s/c, foreign matter.The following was provided by the initial reporter: the customer found that all of their ig1000 irrigation trays seem to have small particles of plastic and fluid within the syringe, seems to be a dust within the entire sealed package.Additional information: can you please provide an exact date of event in format dd-mmm-yyyy? 01-04-2026.
Additional Manufacturer Narrative
Device evaluation it was reported that small plastic particles and fluid were present within the syringe, and that dust-like material appeared to be distributed throughout the sealed package.As a physical sample was not returned, a comprehensive sample evaluation could not be performed.To support the investigation, two photographs were provided and reviewed by the quality team.The images depict a syringe without the blister packaging, with the plunger rod and rubber stopper fully retracted.White-colored particles are visible at the base of the plunger rod.No additional defects or abnormalities were identified from the photographs.A device history record review was conducted for material number 302832, lot 4158775.This review did not identify any quality issues during manufacturing that could have contributed to the reported condition, and no related quality notifications were found.All manufacturing processes and final inspections were completed in accordance with established specifications.Based on the investigation and the photographic evidence, the reported condition is considered confirmed.However, in the absence of a physical sample for evaluation, a definitive root cause could not be determined.

• Brand Name: LUER-LOK
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25503872
• Report Number: 1911916-2026-00310
• Device Sequence Number: 13391868
• Product Code: FMF
• UDI-Device Identifier: 00382903028320
• UDI-Public: (01)00382903028320(10)4158775
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 06/10/2026

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: 302832
• Device Lot Number: 4158775
• 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: 06/05/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown