BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-STREAM

    MDR report key: 2922668 · Received December 27, 2012

    Report

    Report Number
    1213643-2012-00902
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Report Date
    December 3, 2012
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K003790
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED UNITS WERE FOUND TO HAVE CRACKED BLISTER TRAYS. THE BLISTER PACKAGING SEALS WERE NOTED TO HAVE BEEN FULLY FORMED AT ONE TIME. OUR INVESTIGATION DETERMINED THAT IT IS POSSIBLE THAT AN EVENT OF THIS NATURE COULD OCCUR IF THE DEVICES RECEIVED SOME SIGNIFICANT IMPACT DURING THE SHIPPING PROCESS. THE DAMAGE THAT CAN OCCUR TO THE BLISTERS IS A CLEAR BREACH OF THE STERILE BARRIER; HOWEVER, THIS DAMAGE IS HIGHLY EVIDENT TO THE USER. THE IFU CAUTIONS THAT PRODUCT IS STERILE UNLESS PACKAGE IS DAMAGED OR OPEN.

    Description of Event or Problem · 1

    BASED ON INFORMATION REPORTED TO DAVOL: IT WAS REPORTED THAT DURING SET UP FOR A CASE, X-STREAM IRRIGATION UNITS FROM INVENTORY WERE FOUND WITH CRACKED TRAYS. FURTHER REVIEW OF INVENTORY FOUND FIVE ADDITIONAL IRRIGATION UNITS TO BE IN THIS CONDITION. THESE IRRIGATION KITS CAN NOT BE USED AS THE CRACKED PACKAGING CAUSES LOSS OF STERILITY TO THE PRODUCT INSIDE. THERE WAS NO PATIENT INTERVENTION. DUE TO THE REPORTED STERILITY BREACH, THIS MDR IS BEING SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-STREAM GCJ DAVOL INC., SUB. C.R. BARD, INC. NA JUWEF023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA