BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRING WIRE GUIDE COMPONENT

    MDR report key: 1222803 · Received July 10, 2008

    Report

    Report Number
    1036844-2008-00123
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    May 27, 2008
    Report Date
    July 10, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQX
    PMA / PMN Number
    k862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    INFO WAS REC'D BY MAUDE EVENT REPORT. IT WAS REPORTED THAT DURING THE REPLACEMENT OF A RIGHT SUBCLAVIAN TRIPLE LUMEN CATHETER OVER GUIDEWIRE (ON MEETING RESISTANCE WITH INSERTION) THE DECISION WAS MADE TO RETRACT THE GUIDEWIRE. UPON REMOVAL, IT WAS NOTED THAT THE GUIDEWIRE HAD SPLIT INTO 2 PIECES. BOTH PIECES WERE REMOVED AND CAUSED NO PT HARM. THE CENTRAL LINE CATHETER WAS SUCCESSFULLY CHANGED THE FOLLOWING DAY. IN 2008, ADD'L INFO FROM RISK MGR STATED THE GUIDEWIRE ACTUALLY UNRAVELED AND IT WAS REMOVED IN TACT. NO SURGICAL REMOVAL WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRING WIRE GUIDE COMPONENT ADULT MULTI-LUMEN CATHETER PRODUCTS DQX ARROW INTL., INC. * CF7119482

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN