BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOVUE PERIPHERALLY INSERTED CENTRAL CATHETER WITH OCRILON 2

    MDR report key: 229619 · Received June 11, 1999

    Report

    Report Number
    229619
    Event Type
    Injury
    Date Received
    June 11, 1999
    Date of Event
    May 20, 1999
    Report Date
    May 31, 1999
    Manufacturer
    J+J MEDICAL INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BIOVUE PICC LINE PLACEMENT ATTEMPTED. ADVANCED EASILY UNTIL 4" LEFT TO INSERT. PT ENCOURAGED TO RELAX, LINE FLUSHED, AND THEN ADVANCED TO DESIRED LENGTH. GUIDE WIRE THEN REMOVED & MET RESISTANCE ON REMOVAL. WHEN WIRE RELEASED, RN NOTED SEVERE FRAYING OF GUIDE WIRE. CXR OBTAINED WITH LEFT ARM VIEW. FOREIGN BODY NOTED BELOW TOP OF CATHETER THAT HAD LOOPED AT SHOULDER LEVEL BACK DOWN ARM. RE X-RAY SHOWED FOREIGN BODY IN RIGHT LOWER LUNG FIELD. PICC LINE REMOVED. PT TRANSFERRED TO TERTIARY FACILITY. WHEN FOREIGN BODY WAS SUCCESSFULLY REMOVED FROM LUNG. PT TRANSFERRED BACK SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOVUE PERIPHERALLY INSERTED CENTRAL CATHETER WITH OCRILON 2 Implant PICC LINE DQO J+J MEDICAL INC. 97998 15 G 99071 SYRINGE, 99156 GUIDEWIRE

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Hospitalization| O| R