BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 2-LUMEN 7 FR X 8 (20 CM)

    MDR report key: 1842067 · Received August 27, 2010

    Report

    Report Number
    1036844-2010-00262
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 10, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 INDWELLED, THE MD FOUND THE EXTENSION LINE OF THE DISTAL LINE WAS CUT AT THE INJECTION HUB. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE. THIS EVENT HAPPENED THE SAME DAY THE CATHETER WAS INSERTED; HOWEVER, IT IS NOT KNOWN EXACTLY HOW LONG THE CATHETER WAS INDWELLED. IT IS ALSO NOT KNOWN HOW THE LINE BECAME CUT. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 2-LUMEN 7 FR X 8 (20 CM) ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTL., INC. RF9098594

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK