BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPSYSTEM SET

    MDR report key: 7453844 · Received April 24, 2018

    Report

    Report Number
    0008010312-2018-00003
    Event Type
    Malfunction
    Date Received
    April 24, 2018
    Date of Event
    March 6, 2018
    Report Date
    March 6, 2018
    Manufacturer
    H.S. HOSPITAL SERVICE S.P.A.
    Product Code
    KNW
    UDI-DI
    08033003347881
    PMA / PMN Number
    K013692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE (3) NEEDLES HAVE BEEN TESTED. TWO (2) NEEDLES RESULTED DEFECTIVE DURING THE ASPIRATION. CAUSE OF THE PROBLEM IS PROBABLY A LACK OF GLUE DURING ASSEMBLY. WE REPLACED THE DEFECTIVE PRODUCTS TO THE HOSPITAL.

    Description of Event or Problem · 1

    DURING THE BONE MARROW PROCEDURE THE JAMSHIDI NEEDLE HAD A PROBLEM DURING THE ASPIRATION (LACK OF DEPRESSION, 3 NEEDLES WERE DEFECTIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296205 TRAPSYSTEM SET BONE MARROW BIOPSY SET KNW H.S. HOSPITAL SERVICE S.P.A. 29708 08033003347881

    Patients

    Seq Age Sex Outcome Treatment
    1