BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERGLIDE MIDLINE CATHETER

    MDR report key: 4079966 · Received September 8, 2014

    Report

    Report Number
    4079966
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 8, 2014
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO INSERT A MIDLINE IN PT'S LEFT UPPER ARM, THE CATHETER BECAME ACCORDIONED AND ASSISTANCE OBTAINED FROM INTERVENTIONAL RADIOLOGY TO REMOVE DEVICE. DEVICE REMOVED IN ENTIRIETY AND SAVED. REFERENCE #M120081. LOT #REYD0351. NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547603 POWERGLIDE MIDLINE CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM FOZ BARD ACCESS SYSTEMS, INC. * REYD0351

    Patients

    Seq Age Sex Outcome Treatment
    1 *