BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 60CM

    MDR report key: 1001646 · Received February 18, 2008

    Report

    Report Number
    2021898-2008-00049
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    December 26, 2007
    Report Date
    January 25, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K911382
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS UNDER EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL TIP OF THE CATHETER PASSER BROKE OFF IN THE PT DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUBCUTANEOUS CATHETER PASSER, 60CM 84JXG JXG MEDTRONIC NEUROSURGERY NA C05741

    Patients

    Seq Age Sex Outcome Treatment
    1