BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 7306634 · Received March 1, 2018

    Report

    Report Number
    2210968-2018-71127
    Event Type
    Injury
    Date Received
    March 1, 2018
    Report Date
    February 19, 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: WORLD J SURG (2015) 39:727¿731; DOI 10.1007/S00268-014-2860-0 .

    Description of Event or Problem · 1

    TITLE: METHOD OF BILATERAL PLEURAL DRAINAGE BY SINGLE BLAKE DRAIN AFTER ESOPHAGECTOMY AUTHOR(S): YUKIKO NIWA, MASAHIKO KOIKE, HISAHARU OYA, NAOKI IWATA, DAISUKE KOBAYASHI, MITSURO KANDA, CHIE TANAKA, SUGURU YAMADA, TSUTOMU FUJII, GORO NAKAYAMA, HIROYUKI SUGIMOTO, SHUJI NOMOTO, MICHITAKA FUJIWARA, YASUHIRO KODERA. THIS RETROSPECTIVE STUDY AIMED TO EVALUATE THE PERFORMANCE OF BILATERAL PLEURAL DRAINAGE BY A SINGLE 15-F BLAKE DRAIN (BDSD) BY COMPARING ITS FLUID DRAINAGE AND INCIDENCE OF LEFT PLEURAL EFFUSION AND LEFT ATELECTASIS TO THOSE OF A CONVENTIONAL DRAIN. BETWEEN APR2012 AND JUN2014, 104 PATIENTS WITH THORACIC ESOPHAGEAL CARCINOMA UNDERWENT RIGHT TRANSTHORACIC SUBTOTAL ESOPHAGECTOMY. METHODS OF DRAIN PLACEMENT WERE REVIEWED IN TWO GROUPS: BDSD GROUP (N=54; N=48 MALE, N=6 FEMALE; MEAN AGE SD 66±8 YEARS) AND CONVENTIONAL DRAIN (CD) GROUP (N=50; N=42 MALE, N=8 FEMALE; MEAN AGE SD 66±8 YEARS). IN CD GROUP, A 19-F BLAKE DRAIN WAS INSERTED INTO THORACIC CAVITY THOROUGH THE FIFTH INTERCOSTAL MUSCLE AND TIP WAS PLACED IN THE RIGHT DORSAL APICAL AREA, WHILE A 15-F BLAKE DRAIN WAS INSERTED FROM THE LEFT THORACIC CAVITY TO RIGHT THORACIC CAVITY IN BDSD GROUP. FOLLOWING DRAINAGE PLACEMENT, THERE WERE REPORTED CASES OF LEFT PLEURAL EFFUSION (N=40 CD GROUP; N=5 BDSD GROUP) AND LEFT LOWER LOBE ATELECTASIS (N=33 CD GROUP; N=3 BDSD GROUP). FOUR PATIENTS FROM CD GROUP WHO DEVELOPED LEFT PLEURAL EFFUSION NECESSITATES THORACENTESIS. ADDITIONALLY, ONE PATIENT FROM BDSD GROUP HAD LEFT CHEST PAIN THAT WAS THOUGHT TO BE DUE TO THE CONTACT BETWEEN THE DRAIN TIP AND DIAPHRAGM. THE STUDY DEMONSTRATED THAT THE 15-F BLAKE DRAIN WAS ABLE TO EVACUATE BILATERAL PLEURAL EFFUSION MORE EFFECTIVELY AND INCIDENCE OF LEFT PLEURAL EFFUSION AND LEFT ATELECTASIS WERE LOWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150988 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention