BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUIPO DE EXTENSI?N PARA ANESTESIA

    MDR report key: 1913190 · Received December 2, 2010

    Report

    Report Number
    6000001-2010-05413
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - CALI
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE FOUND.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF AN EXTENSION SET FOR ANESTHESIA THAT IS MISSING THE LUER LOCK. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUIPO DE EXTENSI?N PARA ANESTESIA SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - CALI SE10EH2

    Patients

    Seq Age Sex Outcome Treatment
    1