BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 7 FR X 60 CM

    MDR report key: 2013794 · Received February 4, 2011

    Report

    Report Number
    1036844-2011-00035
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 24, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FIELD IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "SOME TIME" AFTER THE CATHETER WAS INDWELLED IN THE PATIENT'S FEMORAL VEIN AND A MEDICAL SOLUTION WAS INJECTED, X-RAYS WERE PERFORMED. IT WAS AT THAT TIME, THE PHYSICIAN FOUND THE SPRING WIRE GUIDE (SWG) REMAINED IN THE CATHETER WHILE THE PT WAS IN THE HOSPITAL WARD. AS A RESULT, THE SWG WAS REMOVED WITH THE CATHETER AND A NEW KIT WAS USED. "WE DON'T HAVE INFO ON HOW LONG THE CATHETER WAS INDWELLED." ADD'L INFO WAS RECEIVED ON 01/31/2011 FROM (B)(6) WHICH STATED "THE ENTIRE SWG WAS LEFT IN THE CATHETER. THERE WAS NO NOTICEABLE DIFFICULTY DURING INJECTION OF THE MEDICAL SOLUTION; THEY DID NOT NOTICE IT WAS IN THE CATHETER UNTIL THE X-RAYS WERE PERFORMED. WE COULD NOT FIND HOW LONG THE SWG WAS THERE, BUT THERE WERE NO ADVERSE ISSUES TO THE PT AT ALL. THE CATHETER AND THE SWG WERE PULLED OUT AS ONE UNIT. NO SURGICAL INTERVENTION WAS NECESSARY TO REMOVE THEM." THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 7 FR X 60 CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. RF0087232

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK