BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL LUMEN CATHETER, TAPERED SEGMENT, 10 FR, 5/PK

    MDR report key: 1051556 · Received May 16, 2008

    Report

    Report Number
    2183680-2008-00011
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    April 17, 2008
    Report Date
    May 15, 2008
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    DQO
    PMA / PMN Number
    K043581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT IS CONFIRMED THAT A PLASTIC FIBER WAS REMOVED FROM THE CATHETER. THIS IS AN OEM PROD, THAT GYRUS ACMI LABELS AND SENDS FOR STERILIZATION. WE ARE AWAITING FURTHER INVESTIGATION OF THE CATHETER BY THE MFR. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. WHEN FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    WHEN THE GUIDEWIRE WAS PUT THROUGH THE CATHETER, A SMALL PIECE OF CURLY PLASTIC FELL OUT INTO THE PT. IT WAS RETRIEVED FROM THE PT WITHOUT INJURY. ANOTHER DEVICE FROM THE SAME LOT NUMBER WAS TESTED OUTSIDE THE PT, AND AGAIN, THE PIECE FELL OUT. THIS PIECE WAS PLACED IN A SMALL TEST TUBE AND SENT IN FOR AN INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL LUMEN CATHETER, TAPERED SEGMENT, 10 FR, 5/PK DUAL LUMEN CATHETER 10 FR DQO GYRUS MEDICAL INC. 608BX 7211016

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK