BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-STREAM

    MDR report key: 2904383 · Received November 29, 2012

    Report

    Report Number
    1213643-2012-00833
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    October 31, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ALLEGED THAT FOUR X-STREAM TUBING SETS WERE RECEIVED WITH CRACKED PACKAGING. THE FOUR DEVICES WERE RETURNED AND VISUAL EXAMINATION CONFIRMED THAT THE UNITS HAD VARIOUS DEGREES OF CRACKED/BROKEN BLISTERS. THE BLISTER PACKAGING SEALS WERE FOUND TO BE COMPLETELY INTACT AND NOT COMPROMISED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PRODUCTION LOT FOUND NO MFG DISCREPANCIES. OUR INVESTIGATION DETERMINED THAT IT IS POSSIBLE THAT AN EVENT OF THIS NATURE COULD NOT OCCUR IF THE DEVICES RECEIVED SOME SIGNIFICANT IMPACT DURING THE SHIPPING PROCESS. THE DAMAGE THAT OCCURRED 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 INFO REPORTED TO DAVOL: FOUR X-STREAM TUBING SETS WERE RECEIVED WITH CRACKED PACKAGING. THE DAMAGE WAS NOTED UPON RECEIPT OF THE PRODUCT AND THERE WAS NO PT 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
    1 X-STREAM GCJ DAVOL INC., SUB. C.R. BARD, INC. NA JUWHF052

    Patients

    Seq Age Sex Outcome Treatment
    1 NA