BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISC

    MDR report key: 1052703 · Received April 23, 2008

    Report

    Report Number
    3002037047-2008-00027
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 25, 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
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE BATCH RECORD VISUAL INSPECTION: NO REMARKS RELATED TO ROTATING LUER LOK ADAPTORS WERE REPORTED. ALL ITEMS ARE VISUALLY INSPECTED. A TEST WAS PERFORMED ON RETENTION SAMPLES; SAMPLES PASSED FUNCTIONALITY TESTING. SOME OF THE LUER LOK ADAPTORS OF THE RETENTION SAMPLES COULD SPIN. A SPINNING LUER LOK ADAPTOR IS NOT CRITERIA FOR REJECTION ACCORDING TO THE DIRECTIONS FOR USE IN THE PACKAGE INSERT THE LUER LOK ADAPTER SHOULD BE FIXED BETWEEN THE FINGERS WHEN CONNECTING THE CANNULA TO PREVENT ROTATION OF THE ADAPTOR.

    Description of Event or Problem · 1

    A FACILITY REPORTED THE PLASTIC ROUND PIECE AT THE END OF THE SYRINGE (WHERE THE NEEDLE IS INSERTED) WAS LOOSE. THEREFORE, IT WAS HARDER TO TIGHTEN/LOCK THE NEEDLE ONTO THE SYRINGE. THE FACILITY STATED THEY USED A DIFFERENT SYRINGE AND COMPLETED THE PROCEDURE WITHOUT IMPACT TO THE PATIENT. THIS OCCURRED FOUR TIMES. THIS IS ONE OF FOUR MEDICAL DEVICE REPORTS BEING REPORTED FOR THIS FACILITY.

    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 08A03I

    Patients

    Seq Age Sex Outcome Treatment
    1 NA