BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL SP125

    MDR report key: 22669284 · Received July 30, 2025

    Report

    Report Number
    1213809-2025-00504
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    July 3, 2025
    Report Date
    August 7, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) - SUPPLEMENTAL MDR - FOREIGN MATTER. ONE PHOTO OF A 5 ML LUER LOCK SYRINGE WAS RECEIVED AND REVIEWED. UPON PHOTO EVALUATION, DARK-COLORED FOREIGN MATERIAL WAS OBSERVED OUTSIDE THE FLUID PATH, SPECIFICALLY AROUND THE BARREL AND SYRINGE TIP. THE CONDITION IS NON-CONFORMING PER PRODUCT SPECIFICATIONS. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE DETAILED EVALUATION AND TO IDENTIFY THE NATURE OF THE OBSERVED FOREIGN MATERIAL. THE POTENTIAL ROOT CAUSE IS ASSOCIATED WITH EITHER THE ASSEMBLY OR PACKAGING PROCESS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 5023092. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: SEALED PACKAGE HAS BROWN SUBSTANCE INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497442 BD SYRINGE 5ML LL SP125 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5023092 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown