BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 8.5 FR X 16CM

    MDR report key: 2021398 · Received February 8, 2011

    Report

    Report Number
    3006425876-2011-00012
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    December 16, 2010
    Report Date
    February 9, 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
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS A (B)(6) OLD MALE IN THE INTENSIVE CARE UNIT. THE CATHETER HAD BEEN IN USE FOR EIGHT DAYS WHEN THE DISTAL PORT BROKE. THE CATHETER WAS REMOVED AND ANOTHER CATHETER PLACED SUCCESSFULLY. THE INSERTION SITES OF THE CATHETERS IS NOT KNOWN. THERE ARE NO REPORTED PT INJURIES, COMPLICATIONS OR DEATH. THE PT OUTCOME IS NOTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 3-LUMEN 8.5 FR X 16CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC ZF0033539

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR