BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTSEED

    MDR report key: 2422845 · Received December 23, 2011

    Report

    Report Number
    9611894-2011-00016
    Event Type
    Malfunction
    Date Received
    December 23, 2011
    Date of Event
    February 17, 2011
    Report Date
    December 19, 2011
    Manufacturer
    NUCLETRON
    Product Code
    KXK
    PMA / PMN Number
    K002429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONFIGURATION OF THIS PACKAGE HAS NOT BEEN CHANGED AND HAS BEEN IN USE FOR 9 YEARS. ONLY ONCE A REPORT WAS MADE THAT THE POUCH WAS RUPTURED. RETESTS OF PACKAGING CONFIGURATION PERFORMED TO GET EVIDENCE ON HOW THE POUCH COULD BE DAMAGED AT THE PAPER SIDE. EXTREME TESTS (PAINT SHAKER) PROVIDED PROOF THAT A LOOSE TOP COVER WOULD ALLOW THE CARTRIDGE TO VIBRATE AND RUPTURE THE PAPER SIDE. DAMAGE TO THE SIDES (SEAL RUPTURE) COULD HOWEVER NOT BE REPRODUCED (EVEN DURING SEVERE TESTING). ALL STERILE SEED CARTRIDGES ARE DOUBLE STERILE PACKED. 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 CUSTOMER RECEIVED TWO BOXES, EACH CONTAINING A SEEDS CARTRIDGE, AS ORDER. WHEN THEY OPENED THE BOXES, EACH STERILE PACKAGE OF EACH CARTRIDGE WAS TORN OPEN (CARTRIDGES NO LONGER STERILE). THE OUTSIDE OF EACH BOX APPEARED UNDAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTSEED SELECT SEED I-125 KXK NUCLETRON 130002 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA