BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 11181849 · Received January 15, 2021

    Report

    Report Number
    1911916-2021-00035
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 21, 2020
    Report Date
    January 14, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 30X1/2 RB HAD DOUBLE NEEDLES AND WAS DAMAGED. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN (B)(6) 2020, THE COMPANY INSPECTED THE BATCH OF INJECTION NEEDLES OF 0022941 AND FOUND THAT 2 INJECTION NEEDLES HAD DOUBLE NEEDLES AND 1 INJECTION NEEDLE¿S LUER INTERFACE WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77249 NEEDLE 30X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 0022941 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1