BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURKEL SAFETY THORACENTESIS SYSTEM-SINGLE

    MDR report key: 275315 · Received April 24, 2000

    Report

    Report Number
    1282497-2000-00002
    Event Type
    Malfunction
    Date Received
    April 24, 2000
    Date of Event
    March 24, 2000
    Report Date
    April 24, 2000
    Manufacturer
    PHOENIX MEDICAL PRODUCTS
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    KENDALL HEALTHCARE RECEIVED REPORT THAT DURING A THORACENTESIS PROCEDURE, THE MD NOTED THAT THE BALL THAT SEATS OVER THE VALVE OF THE SYSTEM WAS NOT SEATING OVER THE HOLE CORRECTLY. IN FACT, MD NOTED SEROUS FLUID IN THE ONE-WAY VALVE. AS A RESULT, CUSTOMER REPORTED THAT AIR WAS INTRODUCED IN THE PLEURAL SPACE AND PT HAD TO BE OBSERVED FOLLOWING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURKEL SAFETY THORACENTESIS SYSTEM-SINGLE THORACENTESIS CATHETER GAA PHOENIX MEDICAL PRODUCTS * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other