BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR CATHETER CLOSED TIP 80CM

    MDR report key: 385600 · Received March 28, 2002

    Report

    Report Number
    2648988-2002-00005
    Event Type
    Malfunction
    Date Received
    March 28, 2002
    Report Date
    March 28, 2002
    Manufacturer
    HEYER-SCHULTE NEUROCARE INC.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY DURING 2 WEEKS IN 2002 HAD EXPERIENCED A PROBLEM WHEN USING INS-5010. WHEN INSERTING THE CATHETER, THE GUIDE WIRE STICKS ONCE IT IS IN THE PATIENT MAKING IT DIFFICULT TO REMOVE, THEREFORE THE CATHETER MUST BE REMOVED AND REPLACED WITH A NEW ONE. THIS HAS OCCURRED APPROX THREE TIMES TO ONE PATIENT. THREE PHYSICIANS HAVE EXPERIENCED THE SAME INCIDENT. THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMBAR CATHETER CLOSED TIP 80CM VENTRICULOSTOMY & EXTERNAL CSF DRAINAGE JXG HEYER-SCHULTE NEUROCARE INC. * 1011671

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention