BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISC

    MDR report key: 1232733 · Received November 14, 2008

    Report

    Report Number
    3002037047-2008-00089
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 15, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED SAMPLE WAS RECEIVED; IT WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE LUER LOK ADAPTOR (LLA) WAS FOUND DETACHED FROM THE BARREL. NO COMPONENT DEFECTS WERE OBSERVED. AFTER REASSEMBLY OF THE DEVICE FOLLOWING THE DIRECTIONS FOR USE (DFU), A FUNCTIONALITY TEST WAS PERFORMED. THE RESULTS WERE AS EXPECTED; THE LLA DID NOT DETACH DURING THIS TEST. INVESTIGATION SHOWED THAT NO REMARKS RELATED TO THIS COMPLAINT WERE REPORTED IN THE BATCH RECORD VISUAL INSPECTION. A FUNCTIONALITY TEST WAS PERFORMED ON THE RETENTION SAMPLES; THE SAMPLES PERFORMED AS EXPECTED. THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED IN THIS LOT OF PRODUCT. THIS REPORT WAS MAILED TO FDA ON: 11/14/2008.

    Description of Event or Problem · 1

    A SURGEON REPORTED THE LUER LOK ADAPTOR (LLA) CAME OFF THE SYRINGE WHEN THE PRODUCT WAS OPENED. THE PRODUCT WAS NOT USED ON A PATIENT. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS REPORT.

    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 08D01C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA