BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VISITEC

    MDR report key: 1707964 · Received May 27, 2010

    Report

    Report Number
    1211998-2010-00004
    Event Type
    Malfunction
    Date Received
    May 27, 2010
    Date of Event
    March 22, 2010
    Report Date
    May 26, 2010
    Manufacturer
    BD OPHTHALMIC SYSTEMS
    Product Code
    LZP
    PMA / PMN Number
    P96001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ASSEMBLED BY (B)(4) USING PRODUCTS FROM BD AND A (B)(4) SUBCONTRACTOR. BD DISTRIBUTES THIS PRODUCT FOR BTG. THE MOLDED FINGER FLANGE ATTACHED TO THE 3ML BD SYRINGE IS NOT A BD MANUFACTURED COMPONENT. BTG WAS CONTACTED TO PROVIDE A RESPONSE. INVESTIGATION FOUND THAT IF THE FINGER FLANGE OPENING IS ORIENTED AWAY FROM THE PALM OF THE HAND, THEN DETACHMENT COULD BE DUPLICATED IF MODERATE PRESSURE WAS APPLIED. NO FAILURE OCCURRED IF THE OPENING IN THE FINGER FLANGE IS ORIENTED TOWARDS THE PALM OF THE HAND. A TELEPHONE CONVERSATION WITH DR (B)(6) INDICATED THAT THE PT IS OK AND SEEING 20/20. NO INTERVENTION WAS REQUIRED. WE ARE CURRENTLY REVIEWING THE IFU FOR ADD'L CLARIFICATION OF THE HANDLING INSTRUCTIONS. A RESPONSE FROM BTG IS PENDING REGARDING THE MOLDED FINGER FLANGE. A FOLLOW-UP REPORT WILL BE PROVIDED APPROX ON 06/25/2010.

    Description of Event or Problem · 1

    (B)(4). THE SURGEON WAS PERFORMING A PHACOEMULSIFICATION ON THE LEFT EYE OF A PT USING BD 1% OVD. AFTER REMOVAL OF THE NUCLEAR FRAGMENTS AND CORTEX, AS THE BAG WAS FILLED WITH VISCOELASTIC, THE ROTATING FINGER FLANGE ON THE SYRINGE POPPED OFF AND THE TIP OF THE BD VISCOFLOW CANNULA (CAT 585026) PIERCED THE POSTERIOR CAPSULE. THE SMALL HOLE BECAME LARGER THROUGH THE VISUAL AXIS. A POSTERIOR CHAMBER SULCUS LENS WAS INSERTED WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD VISITEC 1% OVD SODIUM HYALURONATE LZP BD OPHTHALMIC SYSTEMS NA RD0018A

    Patients

    Seq Age Sex Outcome Treatment
    1