BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT:3-LUMEN 7FR X 2 0CM

    MDR report key: 1842054 · Received August 27, 2010

    Report

    Report Number
    1036844-2010-00264
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 23, 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
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR CONTROL NO. (B)(4) . F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE CATHETER WAS INSERTED, THE PATIENT WAS MOVED FROM THE OPERATING ROOM TO THE INTENSIVE CARE UNIT. IT WAS AT THAT TIME, THE MD NOTICED THE CATHETER HAD BEGUN TO COME OUT OF THE PATIENT. APPROXIMATELY, 14CM OF THE CATHETER WAS INSERTED INTO THE PATIENT. THE CATHETER WAS SECURED ONLY WITH THE CATHETER CLAMP AND FASTENER; THE TRIANGULAR JUNCTION HUB WITH THE INTEGRAL SUTURE RING WAS NOT USED TO SECURE IT. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT:3-LUMEN 7FR X 2 0CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. RF0022703

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK