BEUDAMED
    FDA Adverse Event Other Summary report: N

    DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

    MDR report key: 307301 · Received December 4, 2000

    Report

    Report Number
    1820334-2000-00087
    Event Type
    Other
    Date Received
    December 4, 2000
    Date of Event
    November 6, 2000
    Report Date
    November 8, 2000
    Manufacturer
    COOK INCORPORATED
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PICC LINE PLACEMENT UNDER FLUOROSCOPIC GUIDANCE. ON THE INITIAL ATTEMPT TO PLACE THE LINE, THE DISTAL PORTION OF THE WIRE GUIDE SHEARED OFF IN THE SUBCUTANEOUS TISSUES OF THE UPPER ARM. THE WIRE WAS SHEARED OFF 2CM DEEP TO THE SKIN SURFACE. THE FRAGMENT OF WIRE COULD NOT BE RETRIEVED AND WAS LEFT IN THE SUBCUTANEOUS TISSUES. THIS AREA WAS MARKED AND THE GENERAL SURGEON RESIDENT WAS NOTIFIED OF THIS COMPLICATION. A SECOND PUNCTURE WAS PERFORMED AND THE LINE SUBSEQUENTLY PLACED WITHOUT FURTHER DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER CENTRAL VENOUS CATHETER DQO COOK INCORPORATED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other