BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPULSE SOLO

    MDR report key: 2843564 · Received October 24, 2012

    Report

    Report Number
    1213643-2012-00728
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 28, 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
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS ALLEGED THAT THE STERILE PACKAGING WAS BROKEN ON OPENING. THE SUBJECT PRODUCT WAS NOT RETURNED FOR EVAL. HOWEVER, THERE WERE PICTURES OF THE SUBJECT PRODUCT PROVIDED. THE PICTURES SHOWED A PARTIALLY OPENED BLISTER PACK WITH A CRACK IN THE BLISTER TRAY. THE PORTION OF OPENED BLISTER PICTURE SHOWS THAT THE ORIGINAL BLISTER LID TO BLISTER TRAY. THE PORTION OF OPENED BLISTER PACK WITH A CRACK IN THE BLISTER TRAY SEAL HAD BEEN COMPLETELY FORMED. 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 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 INFO REPORTED TO DAVOL: THE STERILE PACKAGING WAS BROKEN ON OPENING WHEN RECEIVED BY THE USER FACILITY. 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 SOLO FQH DAVOL INC., SUB. C.R. BARD, INC. NA JUWBF151

    Patients

    Seq Age Sex Outcome Treatment
    1