BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISC

    MDR report key: 1171515 · Received September 17, 2008

    Report

    Report Number
    3002037047-2008-00075
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 18, 2008
    Manufacturer
    ALCON - BELGIUM / S.A. ALCON-COUVRUER 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 DEVICE WAS RECEIVED FOR EVALUATION FROM THE FACILITY. THE CANNULA WAS COMPLETELY ATTACHED ON THE SYRINGE; NO LEAKAGE OCCURRED DURING A FUNCTIONALITY TEST. THE LUER LOK ADAPTOR WAS NOT SPINNING; SPINNING DID NOT AFFECT THE FUNCTIONALITY. A SPINNING LUER LOK ADAPTOR IS NOT A DEFECT NOR REJECTION CRITERIA. ACCORDING TO THE DIRECTIONS FOR USE IN THE PACKAGE INSERT, THE LUER LOK ADAPTOR SHOULD BE FIXED BETWEEN THE FINGERS WHEN CONNECTING THE CANNULA TO PREVENT ROTATION OF THE ADAPTOR. RETENTION SAMPLES WERE INSPECTED AND TESTED; SAMPLES MET SPECIFICATIONS. THERE WERE NO REMARKS OR ABNORMAL FINDINGS IN THE BATCH RECORD REVIEW; ALL SYRINGES WERE VISUALLY INSPECTED. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THIS LOT NUMBER.

    Description of Event or Problem · 1

    A SURGEON REPORTED THE CANNULA WAS NOT ABLE TO BE TIGHTENED TO THE LUER LOK ADAPTER (LLA). THE SURGEON ALSO STATED THE SOLUTION LEAKED AROUND THE BARREL TIP AND THE LLA; THE LLA ROTATED EASILY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVISC AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM / S.A. ALCON-COUVRUER N.V. NA 08B18C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA