BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELUTIA

    MDR report key: 2999376 · Received February 26, 2013

    Report

    Report Number
    3008190422-2013-00001
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BACTERIN INTERNATIONAL INC.
    Product Code
    OEI
    PMA / PMN Number
    K063245
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL RELEASED AND DISTRIBUTED PRODUCTION LOTS OF THIS PRODUCT (PN 7118, ELUTIA 24 FR WOUND DRAINS) HAVE BEEN RECALLED UNDER PART 806 (BACTERIN RES (B)(4)). ALL PRODUCT (PN 7118, ELUTIA 24 FR WOUND DRAINS) AT BACTERIN'S MANUFACTURING FACILITY HAS BEEN QUARANTINED. NO PRODUCT (PN 7118, ELUTIA 24 FR WOUND DRAINS) IS BEING DISTRIBUTED. SUMMARY: THE OPENED RETURNED DRAINS EXHIBITED CRACKING OF THE BLUE STRIPE IN THE CHANNEL SECTION, CONFIRMING THE COMPLAINANT'S CLAIMS. NONE OF THE FULLY PACKAGED, RETURNED DRAINS EXHIBITED ANY CHANNEL CRACKING UNTIL THEY WERE MANUALLY PULL-TESTED. THE PARTIAL DELAMINATION DESCRIBED IN (B)(4) COULD BE RECREATED BY PULLING THE CHANNEL SECTION OF THE DRAINS TO A 1.5-FOLD ELONGATION. THE INVESTIGATION INTO THIS COMPLAINT IS ONGOING AND WILL BE DISCUSSED IN ANOTHER MORE COMPREHENSIVE LETTER TO FILE. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    BACTERIN RECEIVED A COMPLAINT (BACTERIN COMPLAINT (B)(4)) THAT A PORTION OF A BACTERIN ELUTIA 24 FR SILICONE WOUND DRAIN WAS FOUND TO BE CRACKED UPON IT'S REMOVAL FROM THE PACKAGE. THE USER SAID THAT SHE OPENED THE 24 FR DRAIN AND SAW THAT THE BLUE PORTION HAD CRACKS IN IT. THE USER DECIDED NOT TO USE THE DRAIN. THE AFFECTED DRAIN AND THE REMAINING DRAINS FROM THE BOX OF 10 WERE RETURNED TO BACTERIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81082 ELUTIA PRODUCT CODE OEI OEI BACTERIN INTERNATIONAL INC. 7118 011012

    Patients

    Seq Age Sex Outcome Treatment
    1