BEUDAMED
    FDA Adverse Event Other Summary report: N

    400CC EVACUATOR W/ 10FR, 1/8"

    MDR report key: 1366117 · Received January 30, 2009

    Report

    Report Number
    1417592-2009-00007
    Event Type
    Other
    Date Received
    January 30, 2009
    Date of Event
    January 10, 2009
    Report Date
    January 21, 2009
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THE INCIDENT INVOLVED A FEMALE PATIENT POST ACL REPAIR. THE DRAIN HAD BEEN INSERTED BY THE SURGEON AND WAS BEING REMOVED LESS THAN 48 HOURS LATER. IT WAS STATED THAT THE DRAIN WAS NOT SECURED WITH SUTURES. WHEN THE DRAIN WAS BEING REMOVED, THE SURGEON PULLED AND THE DRAIN BROKE, LEAVING A PIECE INSIDE THE PATIENT. NO SAMPLE WAS RETAINED FOR EVALUATION. THE LOCATION OF THE BREAK ON THE DRAIN IS NOT KNOWN. THE PATIENT WAS TAKEN BACK TO SURGERY TO HAVE THE PIECE REMOVED. IT WAS REMOVED WITHOUT FURTHER COMPLICATION. THE INCIDENT DID NOT PROLONG THE HOSPITALIZATION. TEN SAMPLES FROM THE SAME LOT WERE TESTED. EACH SAMPLE WAS SECURED ON A TENSILE TESTING APPARATUS AND PULLED AT A CONSTANT RATE. EACH SAMPLE WAS TENSILE TESTED UNTIL IT BROKE. THE FORCE AT BREAK POINT RANGED FROM 14.11 LBS TO 15.52 LBS. WHICH EXCEEDS THE ESTABLISHED SPECIFICATION OF 10 LBS. THE RESULTS OF THIS TESTING DOES NOT SUGGEST ANY PRODUCT FAILURE. IF THE DRAIN HAD BEEN INADVERTENTLY SUTURED DURING THE PROCEDURE, ITS STRENGTH AND INTEGRITY COULD HAVE BEEN COMPROMISED. HOWEVER, DUE TO THE ABSENCE OF THE ACTUAL SAMPLE TO EVALUATE, WE WILL NOT BE ABLE TO DETERMINE A ROOT CAUSE.

    Description of Event or Problem · 1

    UPON REMOVAL OF THE DRAIN, IT WAS REPORTED THAT THE DRAIN BROKE, LEAVING A PIECE INSIDE THE PATIENT. THE PATIENT WAS TAKEN TO SURGERY TO HAVE THE PIECE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 400CC EVACUATOR W/ 10FR, 1/8" WOUND DRAIN GCY MEDLINE INDUSTRIES, INC. DYNJWE402 063008AZC01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention