BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-STREAM

    MDR report key: 3173121 · Received May 30, 2013

    Report

    Report Number
    1213643-2013-00234
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 8, 2013
    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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE SEVEN RETURNED DEVICES CONFIRMED THAT THE UNITS HAD VARIOUS DEGREES OF CRACKED/ BROKEN BLISTERS. THE BLISTER PACKAGING SEALS WERE FOUND TO BE COMPLETELY INTACT AND NOT COMPROMISED. 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 OCCURRED TO THE BLISTERS IS CLEAR BREACH OF THE STERILE BARRIER; HOWEVER, THIS DAMAGE IS HIGHLY EVIDENT TO THE USER. THE IFU CAUTIONS THAT THE 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 WHEN OPENING THE PACKAGING, THE CUSTOMER FOUND SEVEN UNITS OF THE TEN RECEIVED WITH CRACKED/ DAMAGED BLISTER TRAYS THAT COMPROMISED THE STERILITY OF THE PRODUCTS. THE DAMAGE WAS NOTED UPON RECEIPT OF THE PRODUCT AND THERE WAS NO PATIENT INVOLVEMENT AS THE PRODUCT WAS NOT USED. DUE TO THE REPORTED STERILITY BREACH, THIS MDR IS BEING SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239203 X-STREAM GCJ DAVOL INC., SUB. C.R. BARD, INC. NA JUWBF007

    Patients

    Seq Age Sex Outcome Treatment
    1