BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE W/O NEEDLE

    MDR report key: 9781225 · Received March 3, 2020

    Report

    Report Number
    3002682307-2020-00074
    Event Type
    Malfunction
    Date Received
    March 3, 2020
    Date of Event
    February 12, 2020
    Report Date
    March 24, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH SAMPLES OR PHOTOS FOR CATALOG 300296 LOT 1905105 TO INVESTIGATE FOR THIS RECORD. DUE TO THE GLOBAL PANDEMIC, SAMPLES MAY BE DELAYED IN DELIVERY TO THE MANUFACTURING SITES. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD DISCARDIT¿ II SYRINGE W/O NEEDLE HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE SYRINGES DO NOT MEET THE CONDITIONS FOR SAFE USE BECAUSE THEY CONTAIN INSIDE THE PISTON SMALL PARTICLES "PLASTIC", WHICH IS VISIBLE AFTER DRAWING LIQUID INTO THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD DISCARDIT¿ II SYRINGE W/O NEEDLE HAS BEEN FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE SYRINGES DO NOT MEET THE CONDITIONS FOR SAFE USE BECAUSE THEY CONTAIN INSIDE THE PISTON SMALL PARTICLES "PLASTIC", WHICH IS VISIBLE AFTER DRAWING LIQUID INTO THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246846 BD DISCARDIT II SYRINGE W/O NEEDLE SYRINGE FMF BECTON DICKINSON, S.A. 1905105

    Patients

    Seq Age Sex Outcome Treatment
    1 Other