BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPULSE

    MDR report key: 2843712 · Received October 26, 2012

    Report

    Report Number
    1213643-2012-00745
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Report Date
    October 3, 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
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ...THAT A CASE OF TEN SIMPULSE SOLO KITS WERE BEING UNPACKED FROM THE SHIPPING BOX AND PUT ON THE SHELF WHEN IT WAS NOTED THE PRODUCT PACKAGE WAS CRACKED. EIGHT OUT OF THEN WERE CRACKED WITH THE DAMAGE CAUSING A "LOSS OF STERILITY" TO THE PRODUCT AND THEY ARE NO LONGER ABLE TO BE USED. 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: IT WAS ALLEGED THAT A CASE OF TEN SIMPULSE SOLO KITS WERE BEING UNPACKED FROM THE SHIPPING BOX AND PUT ON THE SHELF WHEN IT WAS NOTED THE PRODUCT PACKAGE WAS CRACKED. THE OTHER PRODUCTS ALREADY PLACED ON THE SHELF, FROM THE SAME BOX WERE THEN EXAMINED. EIGHT OUT OF TEN WERE CRACKED WITH THE DAMAGE CAUSING A "LOSS OF STERILITY" TO THE PRODUCT AND THEY ARE NO LONGER ABLE TO BE USED. THE OUTER SHIPPING BOX IS REPORTED TO HAVE NO DAMAGE AT ALL. THE DAMAGE WAS NOTED UPON RECEIPT OF THE PRODUCT AND 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 SIMPULSE FQH DAVOL INC., SUB. C.R. BARD, INC. NA JUWFF474

    Patients

    Seq Age Sex Outcome Treatment
    1