BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON, INC.

    MDR report key: 967141 · Received December 21, 2006

    Report

    Report Number
    967141
    Event Type
    Malfunction
    Date Received
    December 21, 2006
    Date of Event
    November 9, 2006
    Report Date
    November 21, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ADMITTED TO THE HOSPITAL IN 2006 FOR A DECOMPRESSIVE LAMINECTOMY L4-L5 AND PEDICLE SCREW INSTRUMENTATION SECONDARY TO L4-L5 DEGENERATIVE SPONDYLOLISTHESIS. A 10 FRENCH FULLY FLUTED BLAKE DRAIN WAS PLACED IN THE BACK AND BROUGHT OUT THROUGH A SEPARATE STAB WOUND IN THE SKIN. THE RN ON THE POST-OP, NURSING UNIT NOTICED RESISTANCE WHEN SHE TRIED TO REMOVE THE BLAKE DRAIN ON POST OP DAY NUMBER ONE. SHE CALLED THE SURGEON'S PHYSICIAN'S ASST WHO NOTED THAT THE DRAIN SNAPPED WHEN HE TRIED TO REMOVE THE DRAIN. BECAUSE A PORTION OF THE DRAIN WAS RETAINED INSIDE THE PT'S BACK, THE PT WAS TAKEN BACK TO SURGERY IN 2006 FOR REMOVAL OF THE DRAIN. THE SURGEON SAW THE DRAIN UNDER THE FASCIA AND DID NOT UNDERSTAND WHY THE DRAIN DID NOT COME OUT WHEN ATTEMPTS WERE MADE TO REMOVE IT ON THE NURSING UNIT. A LATERAL LUMBAR SPINE WAS TAKEN AT THE END OF THE PROCEDURE TO ASSURE THE PHYSICIAN THAT THERE WERE NO FRAGMENTS OF THE DRAIN LEFT AND THERE WERE NONE SEEN ON THE X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON, INC. BLAKE FULLY FLUTED DRAIN GCY ETHICON, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR