BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESTEP HUBER NEEDLE SET 22G X 0.75IN

    MDR report key: 12308886 · Received August 11, 2021

    Report

    Report Number
    3006260740-2021-03231
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    November 25, 2020
    Report Date
    July 28, 2021
    Product Code
    FPA
    UDI-DI
    00801741066160
    PMA / PMN Number
    K040527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA HEALTH CANADA¿S MEDICAL DEVICES ONLINE DATABASE: "E2401 - INSUFFICIENT INFORMATION F2301 - ADDITIONAL DEVICE REQUIRED A1602 - FAIL-SAFE PROBLEM A040609 - MATERIAL TWISTED / BENT." NO OTHER INFORMATION REGARDING THE EVENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207735 SAFESTEP HUBER NEEDLE SET 22G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR FPA N/A UNKNOWN 00801741066160

    Patients

    Seq Age Sex Outcome Treatment
    1 Other