BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVISC IBC

    MDR report key: 1834426 · Received September 10, 2010

    Report

    Report Number
    3002037047-2010-00138
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    January 1, 2010
    Report Date
    August 13, 2010
    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
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE BATCH RECORDS SHOWED THE FUNCTIONALITY TEST PERFORMED DURING THE BLISTERING OPERATION MET SPECIFICATIONS. THE EXPRESSION FORCE OF THE SYRINGE BATCHES INVOLVED HAS BEEN TESTED AND IS WITHIN SPECIFICATION. FOUR USED COMPLAINT SAMPLES WERE RECEIVED AND NO FURTHER TESTING WAS POSSIBLE ON THE USED SAMPLES. THE SUPPLIERS OF THE SYRINGES HAVE BEEN EVALUATED AND THE MFR HAS FOCUSED ON THE BARREL SUPPLIER WITH THE LOWEST GLIDING FORCE. THE OTHER SUPPLIER HAS BEEN REQUESTED TO FURTHER OPTIMIZE THE GLIDING FORCE OF EMPTY SYRINGES. IN ADDITION, EXPRESSION FORCE TESTING OF FINISHED PRODUCT IS INTRODUCED FROM (B)(6) 2010. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THIS LOT, AND NO REMARKS RELATED TO THIS COMPLAINT HAVE BEEN REPORTED IN THE BATCH RECORD. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INVOLVEMENT" (NO PT INVOLVEMENT). PRODUCT PROBLEM(S): "PLUNGER STICKING" (STICKING [PLUNGER]). A USER FACILITY REPORTED THAT THE PLUNGER STICKS 3/4 OF THE WAY DOWN AND THAT EXCESSIVE FORCE IS REQUIRED FOR INJECTION. THERE WAS NO PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVISC IBC AID, SURGICAL, VISCOELASTIC LZP ALCON - BELGIUM/S.A. ALCON-COUVREUR N.V. NA 10A14N

    Patients

    Seq Age Sex Outcome Treatment
    1