BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II 10 ML SYRINGE

    MDR report key: 9781441 · Received March 3, 2020

    Report

    Report Number
    3002682307-2020-00075
    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
    PL
    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 309110 LOT 1905129 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 WAS REPORTED THAT FOREIGN MATTER OCCURRED BEFORE USE WITH A BD DISCARDIT¿ II 10 ML SYRINGE. THE FOLLOWING INFORMATION WAS 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 IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER OCCURRED BEFORE USE WITH A BD DISCARDIT¿ II 10 ML SYRINGE. THE FOLLOWING INFORMATION WAS 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
    246533 BD DISCARDIT II 10 ML SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1905129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other