BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-STREAM

    MDR report key: 2843720 · Received October 26, 2012

    Report

    Report Number
    1213643-2012-00743
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ALLEGED THAT A BOX OF X-STREAM IRRIGATION TUBING SETS WAS RECEIVED WITH ONE BROKEN BLISTER PACKAGE. THE OUTER BOX WAS NOT DAMAGED. THE DEVICE WAS RETURNED AND VISUAL EXAM CONFIRMED THAT THE UNIT HAD VARIOUS DEGREES OF CRACKED/BROKEN BLISTER. 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 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: A BOX WAS RECEIVED OF X-STREAM IRRIGATION TUBE SETS. THE OUTER BOX WAS NOT DAMAGED BUT ONE OF THE FIVE UNITS WITHIN HAD BROKEN BLISTER PACKAGES. THESE WERE INSPECTED AT INCOMING AND PRIOR TO USE TO ENSURE PACKAGE INTEGRITY, AND THAT THIS ONE HAS A COMPROMISED STERILE BARRIER. THERE WAS NO PT INVOLVEMENT. 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 JUWGF476

    Patients

    Seq Age Sex Outcome Treatment
    1