BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIOX BUBBLE TRAPS

    MDR report key: 2581444 · Received June 10, 2010

    Report

    Report Number
    9681834-2010-00051
    Event Type
    Malfunction
    Date Received
    June 10, 2010
    Date of Event
    May 12, 2010
    Report Date
    May 17, 2010
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    KRL
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED TO TERUMO FOR EVAL. A REVIEW OF THE DHR OF THE INVOLVED PRODUCT CODE FOR THE PERIOD OF THE PAST THREE YEARS CONFIRMED THERE WERE NO INDICATIONS OF PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THERE HAVE BEEN NO PREVIOUS REPORTS FOR THIS PRODUCT CODE. WITH NO LOT NUMBER INFO, THE MFG DATE OF THE ACTUAL DEVICE WAS UNTRACEABLE. THE EXPIRATION OF THIS PRODUCT CODE IS NOT ESTABLISHED DUE TO THE PRODUCT NATURE. THE CAUSE OF THIS EVENT CANNOT BE DETERMINED DUE TO THE ABSENCE OF THE ACTUAL DEVICE AND LOT NUMBER. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING SET-UP, THE HOLDER FOR THE BUBBLE TRAP BROKE. THE PRODUCT WAS CHANGED OUT AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIOX BUBBLE TRAPS BUBBLE TRAP KRL TERUMO CORPORATION, ASHITAKA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK