BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3082315 · Received April 16, 2013

    Report

    Report Number
    1036844-2013-00150
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    COMPLAINT WAS RECEIVED VIA MEDWATCH REPORT. IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED ON A MALE PATIENT IN HIS 70'S. UPON ATTEMPTING TO PLACE NEW CENTRAL LINE OVER GUIDEWIRE, GUIDEWIRE MET RESISTANCE IN CATHETER. DURING REMOVAL OF GUIDEWIRE, GUIDEWIRE SNAPPED INSIDE CATHETER. CATHETER WAS IMMEDIATELY CLAMPED, PULLED AND FULL GUIDEWIRE REMAINS FOUND IN CATHETER. COMPLETELY NEW LINE PLACED. THERE WAS A DELAY IN TREATMENT WITH NO HARM TO THE PATIENT AND NO PATIENT DEATH OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162736 NA ADULT MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1