BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 4 FR X 8 CM

    MDR report key: 1873334 · Received September 17, 2010

    Report

    Report Number
    1036844-2010-00284
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS BEING PERFORMED ON A (B)(6) PT. STOMA CREATED SEVERAL WEEKS/2 MONTHS AGO. PT WAS IN SURGERY FOR STOMA TAKE DOWN AND ANASTOMOSIS; NEEDED CENTRAL VENOUS CATHETER (CVC) FOR TOTAL PARENTERAL NUTRITION (TPN), ANTIBIOTICS AND OTHER MEDICATIONS. DURING INSERTION OF THE CATHETER, THE SPRING WIRE GUIDE (SWG) DID NOT ADVANCE CLEANLY AND RESISTANCE WAS NOTED. IT IS BELIEVED THERE WAS RESISTANCE DURING REMOVAL OF THE SWG AFTER CATHETER WAS ADVANCED. A PIECE OF SWG REMAINED IN PT. APPROXIMATELY 1-2 CM WAS VISIBLE ON X-RAY. IT IS UNK IF THERE WAS A DELAY IN TREATMENT AND THERE WAS NO PT DEATH. ADDITIONAL INFO RECEIVED ON 09/07/2010 FROM THE SALES REP STATED THEY WERE ATTEMPTING TO PLACE THE CATHETER INTO THE PT'S LEFT SUBCLAVIAN. INTRAOPERATIVE ULTRASOUND WAS USED TO LOCATE THE SWG FRAGMENT SEEN ON FLUOROSCOPY. THE SWG FRAGMENT WAS RETAINED IN THE EXTRAVASCULAR SPACE. ANOTHER ATTEMPT WAS NOT MADE AS PT HAD HORRIBLE VENOUS ACCESS. THERE WERE NO PT COMPLICATIONS. FRAGMENT LEFT IN PLACE WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 4 FR X 8 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. RF0020311

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO TPN| ANTIBIOTICS