BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-STREAM

    MDR report key: 2883522 · Received November 15, 2012

    Report

    Report Number
    1213643-2012-00793
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    September 10, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ALLEGED THAT TWO X-STREAM LAPAROSCOPIC IRRIGATION TUBING SETS WERE RECEIVED DAMAGED. THE OUTER SHIPPING BOX DID NOT HAVE ANY DAMAGE. THE TWO DEVICES WERE RETURNED AND VISUAL EXAMINATION CONFIRMED THAT THE UNITS HAD VARIOUS DEGREES OF CRACKED 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 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: IT WAS REPORTED THAT TWO X-STREAM LAPAROSCOPIC IRRIGATION TUBING SETS WERE RECEIVED DAMAGED. THE OUTER SHIPPING BOX DID NOT HAVE ANY DAMAGE. THE DAMAGE WAS NOTED UPON RECEIPT OF THE PRODUCT AND THERE WAS NO PT 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 JUWFF016

    Patients

    Seq Age Sex Outcome Treatment
    1