BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPSYSTEM SET

    MDR report key: 9876931 · Received March 25, 2020

    Report

    Report Number
    9876931
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    January 31, 2020
    Report Date
    March 24, 2020
    Manufacturer
    H.S. HOSPITAL SERVICE S.P.A.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING BONE MARROW BIOPSY. PROVIDER NOTED THE "CAPTURE" COMPONENT OF THE NEEDLE HAD A SMALL BUT NOTICEABLE BEND. A NEW NEEDLE WAS OBTAINED. THE NEW NEEDLE WAS NOTED AS HAVING THAT SAME "CAPTURE" COMPONENT WITH A VERY LARGE (AT LEAST 45 DEGREES) BEND COMING RIGHT OUT OF THE PACKAGING. ANOTHER NEEDLE THAT WAS FREE OF DEFECTS WAS OBTAINED AND THE PROCEDURE WAS COMPLETED. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344258 TRAPSYSTEM SET INSTRUMENT, BIOPSY KNW H.S. HOSPITAL SERVICE S.P.A. TRAPSYSTEM SET 36725

    Patients

    Seq Age Sex Outcome Treatment
    1 27375 DA