BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 7288503 · Received February 22, 2018

    Report

    Report Number
    2210968-2018-70980
    Event Type
    Injury
    Date Received
    February 22, 2018
    Report Date
    February 15, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 9/9/2020.

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: THE AMERICAN JOURNAL OF SURGERY (2015) 210, 1112-1117.

    Description of Event or Problem · 1

    LITERATURE ARTICLE: SURGICAL STABILIZATION OF SEVERE RIB FRACTURES DECREASES INCIDENCE OF RETAINED HEMOTHORAX AND EMPYEMA. THE GOAL OF THIS COHORT STUDY WAS TO EVALUATE THE HYPOTHESIS THAT PATIENTS WHO HAD SURGICAL STABILIZATION OF RIB FRACTURES WITH INTRAOPERATIVE LAVAGE HAVE A LOWER INCIDENCE OF RETAINED HEMOTHORAX (RH), EMPYEMA, AND HOSPITAL READMISSIONS FOR REASON RELATED TO THE THORACIC INJURY COMPARED WITH SIMILARLY INJURED PATIENTS WHO WERE TREATED WITHOUT SURGERY. BETWEEN JAN2009 AND JUN2013, 411 PATIENTS WERE IDENTIFIED FOR ANALYSIS: 137 PATIENTS (N=110 MALE, N=27 FEMALE; MEAN SD AGE 55.9±16.0 YEARS) ON SSRF GROUP AND 274 PATIENTS (N=218 MALE, N=56 FEMALE; MEAN SD AGE 54.6±19.5 YEARS) ON MEDICAL MANAGEMENT OF RIB FRACTURES (MMRF). IN SSRF GROUP, LAVAGE WAS PERFORMED USING A 24FR ROUND BLAKE DRAIN PLACED WITHIN THE PLEURAL CAVITY THROUGH A STAB INCISION SEPARATE FROM THE SURGICAL WOUND. THE PATIENTS HAD AT LEAST 2L OF WARM SALINE INFUSED THROUGH THE DRAIN AND THEN EVACUATED USING SUCTION. AFTER COMPLETION OF LAVAGE, THE DRAIN WAS LEFT IN THE PLEURAL SPACE, SUTURED IN PLACE TO FUNCTION AND CHEST TUBE. AFTER CHEST COMPUTED TOMOGRAPHY, 7 PATIENTS FROM SSRF GROUP MET RADIOLOGIC CRITERIA FOR RH. THREE OF THESE PATIENTS WERE TREATED WITH SIMPLE DRAINAGE. THE STUDY RESULTS INDICATE THAT RIB REDUCTION AND FIXATION, AND THE PLEURAL SPACE IRRIGATION AND EVACUATION THAT ACCOMPANY SSRF, PREVENT RH AND EMPYEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133396 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention