BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 7306150 · Received March 1, 2018

    Report

    Report Number
    2210968-2018-71115
    Event Type
    Injury
    Date Received
    March 1, 2018
    Report Date
    February 20, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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: ANN THORAC SURG. 2009; 87: 1539-45. DOI: 10.1016/J.ATHORACSUR.2009.02.013.

    Description of Event or Problem · 1

    LITERATURE ARTICLE: FLUID DRAINAGE AND AIR EVACUATION CHARACTERISTICS OF BLAKE AND CONVENTIONAL DRAINS USED AFTER PULMONARY RESECTION. THE PURPOSE OF THE PRESENT STUDY IS TO EVALUATE THE PERFORMANCE OF THE BLAKE DRAIN (BD) FR 19 AND 24 USED AS A CHEST TUBE AFTER PULMONARY RESECTION BY COMPARING ITS FLUID DRAINAGE AND AIR EVACUATION CHARACTERISTICS WITH THOSE OF A CONVENTIONAL DRAIN (CD). THIS RETROSPECTIVE STUDY INCLUDES 148 CONSECUTIVE PATIENTS WHO UNDERWENT PULMONARY RESECTION. SEVENTY-FOUR (74) PATIENTS (36 MALE AND 38 FEMALE; AGE RANGE: 20 TO 85 YEARS OLD) WERE MANAGED USING THE BD GROUP. ALL PATIENTS UNDERWENT A SERRATUS ANTERIOR MUSCLE-SPARING THORACOTOMY ACCOMPANIED BY AN ANTERIOR OR A VERTICAL AXILLARY INCISION. THE BD WAS INSERTED AT THE UPPER ANTERIOR AXILLARY LINE OF THE THORACOTOMY IN THE APICAL DIRECTION AND LOOPED TOWARD THE DIAPHRAGM. THIS IS CONSIDERED ADVANTAGEOUS FOR AIR EVACUATION BECAUSE THE SUCTION GROOVES OF THE BD ARE LOCATED CLOSE TO THE APICAL PORTION OF THE THORACIC CAVITY. BASED ON THE SUCTION CONDITIONS USED IMMEDIATELY AFTER SURGERY, THE BD GROUP WAS DIVIDED INTO SUBGROUPS IN WHICH THE DRAIN WAS MANAGED WITH WATER SEAL OR 10 CM OF SUCTION. IT WAS REPORTED THAT THE COMPLICATIONS INCLUDED SUBCUTANEOUS EMPHYSEMA IN 16 PATIENTS AND AIR EVACUATION INSUFFICIENCY THAT DID NOT IMPROVE IN 5 PATIENTS. A CHEST RADIOGRAPH OF 2 PATIENTS THAT WERE CONSIDERED TO HAVE AN AIR EVACUATION INSUFFICIENCY SHOWED 1 PATIENT WITH A TENSION PNEUMOTHORAX AND 1 PATIENT THAT WAS DIAGNOSED WITH A BRONCHOPLEURAL FISTULA WITH MARKED SUBCUTANEOUS EMPHYSEMA WHICH WAS TREATED WITH REPLACEMENT OF THE BD TO A CONVENTIONAL DRAIN (CD) FR 20. IT WAS REPORTED THAT DRAINAGE REQUIREMENTS AFTER PULMONARY RESECTION ARE FUNDAMENTALLY DIFFERENT FROM THOSE AFTER CARDIAC OR OTHER SURGERIES BECAUSE BOTH FLUID DRAINAGE AND AIR EVACUATION REQUIRE CONSIDERATION. TO EVALUATE THE AIR EVACUATION PERFORMANCE OF A CHEST TUBE, IT IS NECESSARY TO CONSIDER THE VOLUME OF AIR EXPELLED FROM THE THORACIC CAVITY THROUGH THE TUBE IN SYNCHRONY WITH EXPIRATION, EXPULSION TIME, FLUID DYNAMIC EQUIVALENT DIAMETER OF THE TUBE, AND SUCTION EFFECT. THE LARGER THE VOLUME OF AIR TO BE EVACUATED AT ONE TIME OR THE SHORTER THE AIR EXPULSION TIME, THE HIGHER THE EVACUATION PRESSURE REQUIRED, WHICH IN TURN RESULTS IN A HIGH INTRATHORACIC PRESSURE LOAD EXERTED ON THE CHEST WALL. THE AUTHORS ALSO CONSIDERED THAT THE SMALLNESS AND FLEXIBILITY OF THE BD MIGHT LEAD TO ITS KINKING OR DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149484 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention