BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

    MDR report key: 1003276 · Received February 27, 2008

    Report

    Report Number
    1820334-2008-00082
    Event Type
    Injury
    Date Received
    February 27, 2008
    Date of Event
    January 2, 2008
    Report Date
    January 28, 2008
    Manufacturer
    COOK INCORPORATED
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: A VISUAL EXAMINATION OF THE RETURNED OPENED, USED AND DAMAGED DEVICE CONFIRMED THE MANDRIL WIRE HAS SEPARATED FROM THE DISTAL WELD CONNECTION, RESULTING IN THE COIL BECOMING ELONGATED. THE CHARACTERISTICS DISPLAYED ALONG WITH THE INFORMATION PROVIDED SUGGEST THAT THE DEVICE MET WITH RESISTANCE BEYOND ITS INTENDED DESIGN, POSSIBLY DUE TO PATIENT ANATOMY AND/OR TECHNIQUE RELATED. WE CAN ADVISE THAT PER THE ATTACHED CAUTION LABEL, IT IS STATED; "WITHDRAWAL OR MANIPULATION OF DISTAL SPRING COIL PORTION OF WIRE GUIDE THROUGH NEEDLE TIP MAY RESULT IN BREAKAGE.

    Description of Event or Problem · 1

    DURING PLACEMENT OF A VENOUS CENTRAL CATHETER IN THE BASILICA VEIN, THE WIRE GUIDE SEPARATED DURING ATTEMPTED REMOVAL, LEAVING A FRAGMENTED PIECE WITHIN THE PATIENT. SURGERY WAS PERFORMED ONE WEEK LATER TO REMOVE THE SEPARATED PORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER DQY - CENTRAL VENOUS CATHETER LJS COOK INCORPORATED NA F2018189

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention