BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISC

    MDR report key: 1070139 · Received July 3, 2008

    Report

    Report Number
    3002037047-2008-00050
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 5, 2008
    Manufacturer
    ALCON - BELGIUM/ S.A. ALCON-COUVREUR N.V.
    Product Code
    LZP
    PMA / PMN Number
    P890047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING WAS PERFORMING ON RETENTION SAMPLES. THE RETENTION SAMPLES PASSED ALL FUNCTIONALITY TESTS. ACCORDING TO THE DIRECTIONS FOR USE IN THE PACKAGE INSERT, THE LLA SHOULD BE FIXED BETWEEN THE FINGERS WHEN CONNECTING THE CANNULA TO PREVENT ROTATION OF THE ADAPTOR DURING SET-UP. TESTING WAS CONDUCTED ON THE RETURNED SAMPLE. THE RETURNED SAMPLE MET FUNCTIONAL AND PERFORMANCE SPECIFICATIONS. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THIS LOT NUMBER. THIS REPORT WAS MAILED TO FDA ON: 07/03/2008.

    Description of Event or Problem · 1

    A NURSE REPORTED THE LUER LOK ADAPTER (LLA) WAS NOTED TO "NOT BE FIXED" WHILE ATTACHING THE CANNULA TO THE SYRINGE DURING SETUP. IT WAS REPORTED THERE WAS NO PATIENT INVOLVEMENT OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVISC AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM/ S.A. ALCON-COUVREUR N.V. NA 08A02K

    Patients

    Seq Age Sex Outcome Treatment
    1 NA