BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VISITEC

    MDR report key: 1881204 · Received October 5, 2010

    Report

    Report Number
    1211998-2010-00006
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 13, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BD OPHTHALMIC SYSTEMS
    Product Code
    HMX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN IF A COMPLAINT SAMPLE IS AVAILABLE AT THIS TIME. THIS DEVICE IS ASSEMBLED BY (B)(4) USING PRODUCTS FROM (B)(4) AND (B)(4) AND (B)(4). (B)(4) DISTRIBUTES THIS PRODUCT FOR (B)(4). THE MOLDED FINGER FLANGE ATTACHED TO THE 3ML BD SYRINGE IS NOT (B)(46) COMPONENT. A SIMILAR COMPLAINT WAS RECEIVED IN (B)(4) 2010 FOR THE FINGER FLANGE "POPPING OFF" THE SYRINGE. INVESTIGATION FOUND THAT WHEN THE FINGER FLANGE OPENING WAS ORIENTED AWAY FROM THE PALM OF THE HAND, DETACHMENT COULD BE DUPLICATED WHEN 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 (B)(4) FOR THE (B)(4) COMPLAINT INDICATED THAT CAPA (B)(4) CHANGED MOLDING VENDORS FOR THE FINGER FLANGE AFTER THEY RECEIVED ONE COMPLAINT FROM A CUSTOMER REPORTING THE FINGER FLANGE ROTATED. IT SHOULD BE NOTED THAT THE FINGER FLANGE IS INTENDED TO ROTATE, HOWEVER, THEIR INVESTIGATION DETERMINED THE FLANGE ROTATED TOO EASILY. THE MOLD WAS MODIFIED AND A NEW VENDOR APPROVED TO MOLD THE NEW PART. THE NEW MOLD BEGAN WITH LOT RD0070A. AT THAT TIME, (B)(4) DETERMINED THAT NO CHANGE WAS NEEDED TO THE IFU. (B)(4) WAS CONTACTED TO REQUEST A CONFERENCE CALL TO PROVIDE INFO REGARDING THE MOLD MODIFICATION, VENDOR SELECTION AND CORRECTIVE ACTION. NO RESPONSE WAS RECEIVED AT THIS TIME. A FOLLOW-UP REPORT WILL BE PROVIDED APPROXIMATELY (B)(4).

    Description of Event or Problem · 1

    (B)(4). ON (B)(6) A CUSTOMER COMPLAINT REPORTED, "DURING SURGICAL PROCEDURE AFTER PHACOEMULSIFICATION, HANDLE OF VISCOELASTIC SYRINGE DISENGAGED AND THE SYRINGE BECAME UNSTABLE WHICH CAUSED THE CANNULA OF VISCOELASTIC TO INADVERTENTLY RUB THE CORNEAL ENDOTHELIUM." A TELEPHONE CONVERSATION WITH (B)(6) ON (B)(6) 2010, STATED THAT SHE DID NOT HAVE A LOT NUMBER. (B)(4). THE INCIDENT OCCURRED ON (B)(6). IT IS LIKELY THAT THE LOT USED WAS FROM LOT RD0070A. A CONVERSATION WITH (B)(6) ON (B)(6) 2010 INDICATED A CATARACT PROCEDURE WAS PERFORMED ON A PT AND THE FLANGED PIECE THAT FITS ON THE SYRINGE FLEW OUT OF HIS HAND AND HIT THE PT'S EPITHELIUM. AS A RESULT, THE FACILITY REMOVES THE FLANGED PART ON THE SYRINGE. PT REQUIRES SECONDARY SURGERY (DSAEK).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention