BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUR IRRIGATION SET Y-TYPE

    MDR report key: 462437 · Received May 21, 2003

    Report

    Report Number
    9615050-2003-00092
    Event Type
    Malfunction
    Date Received
    May 21, 2003
    Date of Event
    May 1, 2003
    Report Date
    May 6, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    EYZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN UNDOCUMENTED NUMBER OF INCIDENTS OF IRRIGATION TUBING SET DISCONNECTION AND SPLITTING. THE CUSTOMER REPORTED THAT DURING CYSTOSCOPY PROCEDURES, THE DISTAL END OF THE TUBING SETS ARE BECOMING DISCONNECTED FROM THE STOPCOCK. THERE WAS NO PT SPECIFIC OR EVENT DATA PROVIDED. IT WAS REPORTED THAT ON ONE OCCASION THE SURGEON AND MONITOR WERE SPRAYED WITH AN UNSPECIFIED FLUID. THE REPORTER STATED THAT WHEN THE DISTAL END OF THE TUBING SET COMES IN CONTACT WITH FLUID, THE DISTAL END OF THE TUBING BECOMES LOOSE. THIS IS ESPECIALLY NOTED TO OCCUR WHEN THE SCOPES ARE CHANGED AND THE TUBING IS ATTACHED ELSEWHERE. THE TUBING THEN SPLITS APPROXIMATELY 1/4TH OF AN INCH ALONG THE LONGITUDINAL LINES ON THE DISTAL END OF THE SET. THERE WAS NO REPORTED PT ADVERSE PT EVENT. ALTHOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUR IRRIGATION SET Y-TYPE INRRIGATION SET EYZ ABBOTT LABORATORIES NA 920875H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other UNK LIST AND LOT NUMBER.| CIRCO UNIVERSAL STAINLESS STELL STOPCOCK.