BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 22154994 · Received June 5, 2025

    Report

    Report Number
    9614033-2025-00049
    Event Type
    Malfunction
    Date Received
    June 5, 2025
    Date of Event
    April 15, 2025
    Report Date
    July 3, 2025
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    50382903010733
    PMA / PMN Number
    NA
    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

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 5ML LL BNS. HAD LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 304656. BATCH#: 4193557. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. COMPLAINT NUMBER(S): (B)(4). PRODUCT SKU: 26001 (DNQSYR 3ML L/L) VENDOR PART NO 301073) 153245 (DNQSYRINGE 5ML LL BNS) VENDOR PART NO 304656) LOT 4193557. PRODUCT LOT NUMBER: UNKNOWN. COMPLAINT DETAILS: ¿DATE OF EVENT 4/15/2025. IT WAS REPORTED THAT SYRINGES 3ML AND 5ML ARE "FAILING AND THE MEDS ARE GOING UP INTO THE SYRINGE ABOVE THE PLUNGER SEAL". DUE TO THIS, A NEW DEVICE IS REQUIRED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462571 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 4193557 50382903010733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown