BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPULSE

    MDR report key: 2843718 · Received October 26, 2012

    Report

    Report Number
    1213643-2012-00741
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Report Date
    October 1, 2012
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FQH
    PMA / PMN Number
    K942886
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ALLEGED THAT THE OPERATING ROOM WAS UNPACKING SIMPULSE PRODUCTS AND TWO OF THE TEN PACKAGES WERE BROKEN AT THE EDGE WITH AN OPENING IN WHICH THE PRODUCT WAS VISIBLE. THE TWO DEVICES WERE RETURNED AND VISUAL EXAMINATION CONFIRMED THAT THE UNITS HAD VARIOUS DEGREES OF CRACKED/BROKEN BLISTERS. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PRODUCT LOT FOUND NO MANUFACTURING 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 INFORMATION REPORTED TO DAVOL: THE OPERATING ROOM WAS UNPACKING SIMPULSE PRODUCTS WHEN THEY NOTED THAT TWO PRODUCTS OUT OF A CASE OF TEN WERE BROKEN AT THE EDGE WITH AN OPENING IN WHICH THE PRODUCT WAS VISIBLE. THE OUTER BOX WAS NOT DAMAGED. THE DAMAGE WAS NOTED UPON RECEIPT OF THE PRODUCT AND THERE WAS NO PATIENT INVOLVEMENT. DUE TO THE REPORTED STERILITY BREACH, THIS MDR IS BEING SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPULSE FQH DAVOL INC., SUB. C.R. BARD, INC. NA JUWFF183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA