BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T CONNECTOR WITH MALE LUER SLIP

    MDR report key: 298677 · Received September 27, 2000

    Report

    Report Number
    1526863-2000-00116
    Event Type
    Malfunction
    Date Received
    September 27, 2000
    Date of Event
    September 25, 2000
    Report Date
    September 25, 2000
    Manufacturer
    MEDEX
    Product Code
    FKB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THE T-CONNECTOR LEAKED AT THE TUBING AND THE T-SITE. DURING IN-HOUSE EVAL, IT WAS DETERMINED THAT THE TUBING WAS CUT. NO PT INJURY OR TREATMENT WAS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 T CONNECTOR WITH MALE LUER SLIP T CONNECTOR FKB MEDEX NA 29B160048

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN