BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAERVELDT SHUNT

    MDR report key: 6216741 · Received December 30, 2016

    Report

    Report Number
    9614546-2016-00730
    Event Type
    Malfunction
    Date Received
    December 30, 2016
    Date of Event
    December 8, 2016
    Report Date
    February 10, 2017
    Manufacturer
    ABBOTT MEDICAL OPTICS
    Product Code
    KYF
    UDI-DI
    05050474512993
    PMA / PMN Number
    K955455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PRODUCT WAS INSPECTED BY A QUALIFIED INSPECTOR USING A 12X MAGNIFICATION. INVESTIGATION SHOWS THAT THE TUBE IS BROKEN. INVESTIGATION OF THE RETURN SAMPLE AND THE CONDITION OF THE RETURN SAMPLE DO NOT SUGGEST THE DAMAGE WAS INTRODUCED DURING MANUFACTURING. THE REPORTED ISSUE WAS NOT VERIFIED. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE PRODUCT WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATIONS. A SEARCH REVEALED THAT NO ADDITIONAL SIMILAR COMPLAINTS FOR THIS ORDER NUMBER HAVE BEEN RECEIVED. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) WERE REVIEWED. THE DFU ADEQUATELY PROVIDE INSTRUCTIONS AND PRECAUTIONS ALONG WITH WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. CONCLUSION: AS A RESULT OF THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE TUBE OF A BAERVELDT SHUNT WAS NOT DRAINING THE FLUID. THE TUBE WAS INTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866544 BAERVELDT SHUNT SURGICAL ADJUNCTS KYF ABBOTT MEDICAL OPTICS BG101-350 05050474512993

    Patients

    Seq Age Sex Outcome Treatment
    1