BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MD - DISPOSABLE

    MDR report key: 1812895 · Received August 24, 2010

    Report

    Report Number
    6000001-2010-02715
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THE PRODUCT CODE AND LOT NUMBER ARE NOT KNOWN: THEREFORE A BATCH REVIEW WILL NOT BE PERFORMED AND THE 510K IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT RADIO-ISOTOPES WERE BEING INJECTED THROUGH AN UNKNOWN CLEARLINK CATHETER EXTENSION SET, PRODUCT CODE UNKNOWN (EITHER 2N8374 OR 2N8378), LOT NUMBER UNKNOWN, AND IT LEAKED. THE CONDITION OCCURRED IN THE NUCLEAR MEDICINE DEPARTMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MD - DISPOSABLE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1