BEUDAMED
    FDA Adverse Event Other Summary report: N

    REUSABLE CATHETER PASSER

    MDR report key: 485425 · Received September 15, 2003

    Report

    Report Number
    2518608-2003-00003
    Event Type
    Other
    Date Received
    September 15, 2003
    Date of Event
    September 5, 2003
    Report Date
    September 9, 2003
    Manufacturer
    PHOENIX BIOMEDICAL
    Product Code
    GBS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE REUSABLE CATHETER PASSER IS A NON-STERILE STAINLESS STEEL INSTRUMENT. THE INSTRUCTION FOR USE IDENTIFIES THE PRODUCT AS NON-STERILE AND INDICATES THE STEAM STERILIZATION PROCEDURES. THE PRODUCT LABEL ALSO STATES THAT THE PRODUCT IS NON-STERILE. HOWEVER, THE LABEL USED, CAN BE USED FOR EO STERILIZATION. IT STATES "STERILE, EO", "STERILE UNLESS INNER PACKAGE IS OPEN OR DAMAGED" AND "INDICATOR DOT TURNS BROWN WHEN STERILE", ALTHOUGH THE EO INDICATOR DOT ON THE LABEL IS BLUE INDICATING THAT IT HAS NOT BEEN EXPOSED TO EO GAS. BECAUSE OF THE CONFLICTING STATEMENTS ON THE LABEL, STERILITY OF THE PRODUCT IS NOT CLEAR. AS A RESULT, NON-STERILE PRODUCT WAS USED ON A PT. THIS EVENT WAS DISCOVERED THE SAME DAY AND THE PT IS BEING TREATED WITH ANTIBIOTICS, AND INFECTION HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REUSABLE CATHETER PASSER CATHETER PASSER GBS PHOENIX BIOMEDICAL * K0701

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other