BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLETCHER CT/MR APPLICATOR SET

    MDR report key: 2422822 · Received December 23, 2011

    Report

    Report Number
    9611894-2011-00013
    Event Type
    Malfunction
    Date Received
    December 23, 2011
    Date of Event
    August 7, 2009
    Report Date
    December 23, 2011
    Manufacturer
    NUCLETRON BV
    Product Code
    JAK
    PMA / PMN Number
    K983341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FORCE APPLIED TO APPLICATOR COULD BE CAUSED BY ANATOMY OF THE PT OR PT MOVING FROM BACK, TO SIT POSITION. FORCE APPLIED TO IU TUBE IS SIMULATED. IN "NORMAL" CLINICAL SITUATION, THE BENDING OF THE IU TUBE TIP IS FOR ABOUT 5MM, THIS MEANS A FORCE OF 2.5N APPLIED TO THE TIP. PRODUCT IS NOT REPRODUCIBLE, NOR WITH THE PRODUCT WHICH WAS RETURNED, PROBLEM DETERMINED TO BE AN ISOLATED ISSUE. AS A RESULT OF THE FDA FORM 483 REPORT FEI NUMBER (B)(4) DATED (B)(4), 2011, NUCLETRON BV IS NOW SUBMITTING THIS MDR IN COMPLIANCE WITH THE CORRECTIVE ACTIONS OF THE FDA FORM 483.

    Description of Event or Problem · 1

    THE IU TUBE SPLIT IN HALF WHILE INSIDE THE PT JUST ABOVE WHERE THE WHITE PLASTIC MEETS THE BLACK BASE. IT OCCURRED SOMETIME BETWEEN THE SURGERY AND THE CT. THE PT WAS NOT TREATED; THEY DISCOVERED THE BREAK WHILE HAVING PROBLEMS INSERTING THE X-RAY MARKER. THE PT WAS CT'D AND TANDEM WAS THEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLETCHER CT/MR APPLICATOR SET FLETCHER WILLIAMSON APPLICATOR SET JAK NUCLETRON BV 189745-03 004435

    Patients

    Seq Age Sex Outcome Treatment
    1 NA