BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 19GA 1-1/2IN TW

    MDR report key: 9844585 · Received March 17, 2020

    Report

    Report Number
    3002682307-2020-00096
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    February 26, 2020
    Report Date
    March 24, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    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 BEEN PROVIDED WITH THE AFFECTED SAMPLE FOR CATALOG 301500 LOT 190617 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE SAMPLE SHOWS A BLISTER ALREADY OPENED AND THE REPORTED FAILURE MODE COULD NOT BE REPRODUCED. THE FLAP HAS THE CORRECT SIZE AND ANY ISSUE THAT COULD AFFECT THE PROPERLY OPENING OF THE BLISTER COULD NOT BE SEEN. 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 NEEDLE 19GA 1-1/2IN TW PACKAGING TORE AND LEFT PAPER SHARDS IN THE STERILE FIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PACKAGING OF STERILE CANNULAS CAN ONLY BE OPENED IN A VERY INCONVENIENT WAY -> NO LONGER STERILE."

    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 WAS REPORTED THAT NEEDLE 19GA 1-1/2IN TW PACKAGING TORE AND LEFT PAPER SHARDS IN THE STERILE FIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PACKAGING OF STERILE CANNULAS CAN ONLY BE OPENED IN A VERY INCONVENIENT WAY. NO LONGER STERILE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309287 NEEDLE 19GA 1-1/2IN TW NEEDLE FMI BECTON DICKINSON, S.A. 190617

    Patients

    Seq Age Sex Outcome Treatment
    1 Other