BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C SET: 3-LUMEN 5.5 FR X 13 CM

    MDR report key: 1994257 · Received January 14, 2011

    Report

    Report Number
    1036844-2011-00003
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    September 27, 2010
    Report Date
    January 10, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    UNKNOWN

    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 THE CATHETER HAD BEEN SUCCESSFULLY PLACED ON (B)(6) 2010, AND ON (B)(6)2010, LEAKAGE WAS OBSERVED. THE CATHETER WAS WITHDRAWN FROM THE PT AND A NEW (B)(4) WAS INSERTED SUCCESSFULLY. THE INSERTION SITE IS UNK. THERE WERE NO REPORTED PT COMPLICATIONS, INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C SET: 3-LUMEN 5.5 FR X 13 CM PEDIATRIC MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC RF9030074

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO