BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ SYRINGE

    MDR report key: 14131782 · Received April 16, 2022

    Report

    Report Number
    3002682307-2022-00117
    Event Type
    Malfunction
    Date Received
    April 16, 2022
    Date of Event
    February 10, 2022
    Report Date
    June 6, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309110 AND LOT NUMBER 2111265. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, OUR QUALITY TEAM COULD NOT COMPLETE A THOROUGH SAMPLE ANALYSIS AND AN EXACT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED BD DISCARDIT¿ SYRINGE HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE MEDICATION WAS PUSHED OUT "BACKWARDS" NEXT TO THE PLUNGER OF THE SYRINGE INSTEAD OF OVER THE CONE OF THE SYRINGE".

    Description of Event or Problem · 0

    IT WAS REPORTED BD DISCARDIT¿ SYRINGE HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE MEDICATION WAS PUSHED OUT "BACKWARDS" NEXT TO THE PLUNGER OF THE SYRINGE INSTEAD OF OVER THE CONE OF THE SYRINGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907155 BD DISCARDIT¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2111265

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown