BEUDAMED
    FDA Adverse Event Other Summary report: N

    CVC KIT: 2-LUMEN 5 FR X 55 CM

    MDR report key: 707069 · Received May 1, 2006

    Report

    Report Number
    1036844-2006-00031
    Event Type
    Other
    Date Received
    May 1, 2006
    Date of Event
    April 18, 2006
    Report Date
    May 1, 2006
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PICC WAS PLACED SUCCESSFULLY IN 06 VIA RIGHT BASILIC VEIN. PT DISCHARGED IN 3/06. PT RE-ADMITTED TO HOSP IN 03 WITH COMPLICATIONS UNRELATED TO PICC. IN 4/06, SWELLING WAS REPORTED NEAR PICC INSERTION SITE. PICC WAS REMOVED DUE TO SUSPECTED INFECTION. IT APPEARED MIDDLE OF CATHETER HAD BURST. UNK IF PRESSURE INJECTOR HAD BEEN USED AT THIS FACILITY OR ANOTHER. HOSP CUT DISTAL END AT INSERTION. NO ASSOCIATED PT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 5 FR X 55 CM PERIPHERALLY INSERTED CENTRAL CATHETERS FOZ ARROW INTERNATIONAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other