BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURKEL SAFETY THORACENTESIS SYSTEM-SINGLE

    MDR report key: 281948 · Received June 12, 2000

    Report

    Report Number
    1282497-2000-00004
    Event Type
    Malfunction
    Date Received
    June 12, 2000
    Date of Event
    May 10, 2000
    Report Date
    June 9, 2000
    Manufacturer
    PHOENIX MEDICAL PRODUCTS
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    KENDALL HEALTH CARE RECEIVED REPORT FROM HOSP ON 05/10/00, THAT DURING A THORACENTESIS PROCEDURE, THE RADIOLOGIST COULD AIR LEAKING IN THE LINE DURING THE PROCEDURE. MD DID NOT KNOW IF AIR IS COMING FROM THE PT DURING THE PROCEDURE OR WAS AIR ENTERING THE CATHETER THROUGH THE VALVE. MD REPORTS NOT FEELING CREPITUS. NO PT INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURKEL SAFETY THORACENTESIS SYSTEM-SINGLE THORACENTESIS CATHETER GAA PHOENIX MEDICAL PRODUCTS 8888566034 00126

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other