BEUDAMED
    FDA Adverse Event Other Summary report: N

    V.CATH PICC

    MDR report key: 557947 · Received December 6, 2004

    Report

    Report Number
    2925153-2004-00027
    Event Type
    Other
    Date Received
    December 6, 2004
    Date of Event
    October 26, 2004
    Report Date
    December 3, 2004
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN NURSE WAS REMOVING THE STYLET (GUIDEWIRE), SHE FELT SOME RESISTANCE. THE CATHETER WAS KINKED AND RIPPED DURING THE GUIDE-WIRE REMOVAL. THE SURGEON REMOVED SUCCESSFULLY THE ENTIRE CATHETER VIA FLUOROSCOPY INTERVENTION. THERE WAS NO PT HARM OR INJURY, PT WAS STABLE AND FINE AND RETURNED HOME ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V.CATH PICC 3FR V.CATH DQO HDC CORP. 303-166 1009

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other