BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 13172542 · Received January 5, 2022

    Report

    Report Number
    2210968-2022-00099
    Event Type
    Injury
    Date Received
    January 5, 2022
    Date of Event
    May 1, 2021
    Report Date
    January 5, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED TO DATE. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED: UNKNOWN BLAKE DRAIN CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (DIAPHRAGM PARALYSIS, HOSPITAL READMISSION) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS: UNKNOWN BLAKE DRAIN USED IN THIS PROCEDURE? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY (2021);161(5):1618-1622. HTTPS://DOI.ORG/10.1016/J.JTCVS.2020.05.121.

    Description of Event or Problem · 0

    TITLE: ASSOCIATION OF CHEST TUBE POSITION WITH PHRENIC NERVE PALSY AFTER NEONATAL AND INFANT CARDIAC SURGERY THIS RETROSPECTIVE COHORT ANALYSIS AIMS TO TEST THE HYPOTHESIS THAT CHEST TUBES IN CONTACT WITH THE PHRENIC NERVE IN THE PLEURAL APEX MAY CAUSE PRESSURE PALSY, CONTRIBUTING TO CLINICAL DIAPHRAGM PARESIS OR DIAPHRAGM PARALYSIS (DP). A PREINTERVENTION AND POSTINTERVENTION ANALYSIS OF 531 PATIENTS (298 MALE AND 233 FEMALE; WITH AGE <1 YEAR) BETWEEN JANUARY 1, 2012, AND JUNE 22, 2019, WAS PERFORMED TO EVALUATE ANY IMPACT OF POSITIONING AND DURATION OF CHEST TUBES. ALL PATIENTS UNDERWENT CONGENITAL HEART SURGERY WITH CARDIOPULMONARY BYPASS WHO HAD RIGHT-SIDED 19 FR BLAKE CHEST TUBE (ETHICON, SOMERVILLE, NJ) CONNECTED TO A PLEUR-EVAC SYSTEM (TELEFLEX MEDICINE, MORRISVILLE, NC) PLACED IN THE COURSE OF OPERATION. REPORTED COMPLICATIONS INCLUDE RIGHT DIAPHRAGM PARALYSIS (N=32) AND 30-DAY READMISSION (N=109). IN CONCLUSION, CHEST TUBES THAT OCCUPY THE RIGHT SUPERIOR PLEURAL SPACE ARE ASSOCIATED WITH INCREASED RISK OF DP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616521 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention