BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 4066650 · Received August 14, 2014

    Report

    Report Number
    3008845715-2014-00032
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Report Date
    August 14, 2014
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC. ANGIOTECH PR INC.
    Product Code
    NEW
    PMA / PMN Number
    K113744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED WILL NOT BE RETURNED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED. FINISHED GOOD PRODUCT WAS RECEIVED INTO INVENTORY WITHOUT QUALITY ISSUES. THE PRODUCT FROM THIS FINISHED GOOD LOT AND ALL OF THE COMPONENTS MET SURGICAL SPECIALTIES PUERTO RICO INC. REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. NO INVENTORY AVAILABLE. NEEDLE SUPPLIER, WHICH IS OUR CUSTOMER AS WELL, WAS CONTACTED TO VERIFY IF THERE WERE ANY QUALITY ISSUES RELATED TO THE NEEDLE BATCHES USED IN THE MANUFACTURING OF THE LOTS REVIEWED. SUPPLIER CONFIRMED THAT NO NCRS WERE GENERATED AS PART OF THE MANUFACTURING PROCESS OF THE NEEDLE LOTS. FINISHED GOOD PRODUCT WERE RECEIVED INTO INVENTORY WITHOUT QUALITY ISSUES. THE NEEDLE SUPPLIER HAS BEEN MADE AWARE OF THIS COMPLAINT FOR A CONTINUED INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "THE NEEDLE THAT WAS USED TO SUTURE VAGINAL CUFF BROKE DOWN. IT IS GRAYED. THE OTHER PACKAGE OF STRATAFIX SUTURE THAT WE OPENED ALREADY CAME LOOPED." PR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486787 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. ANGIOTECH PR INC. SXPD1B40105 MCNR560

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE MADE AVAILABLE