BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 7 FR X 16 CM

    MDR report key: 1230369 · Received November 7, 2008

    Report

    Report Number
    3006425876-2008-00008
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    September 19, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ARROW INTL INC
    Product Code
    DQO
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS EVENT INVOLVED A FEMALE PATIENT VIA A RIGHT INTERNAL JUGULAR VEIN WITHOUT EVENT. HOWEVER, RESISTANCE WAS NOTED WHILE ATTEMPTING TO "WITHDRAW" SLIGHTLY AGAINST THE SPRING WIRE GUIDE (SWG). THERE WERE FURTHER ATTEMPTS TO INSERT THE SWG, WHICH FACED RESISTANCE AS PREVIOUSLY. THE ANESTHETIST FAILED TO REMOVE THE SWG DUE TO THE FACT THAT IT "UNROLLED". ALSO, THE PHYSICIAN MET RESISTANCE WHILE ATTEMPTING TO REMOVE THE INJECTION NEEDLE AND SWG TOGETHER. THE DOCTOR USED A "BIT" OF FORCE TO REMOVE BOTH THE NEEDLE AND THE SWG. THE SWG APPEARED TO HAVE A "BREAK" IN IT. ALSO, THERE APPEARED TO BE A HEMATOMA ON THE PATIENT'S NECK. AS A RESULT, ANOTHER KIT WAS OPENED (WITH THE SAME LOT NUMBER) AND INSERTED SUCCESSFULLY INTO THE LEFT SIDE OF THE PATIENT WITHOUT ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 7 FR X 16 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTL INC ZF8038002

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR