BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EQUAL Y CONNECTOR 1/4

    MDR report key: 16277046 · Received February 1, 2023

    Report

    Report Number
    16277046
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Date of Event
    December 16, 2022
    Report Date
    January 20, 2023
    Manufacturer
    NOVOSCI CORP.
    Product Code
    KRI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NARRATIVE FROM STAFF: Y CONNECTOR NOT DRAINING. NOTED THAT IT WAS DEFECTIVE AND CHANGED OUT. IT WAS NOTED THAT THE CHEST TUBE NOT DRAINING WHEN EXAMINED NOTED THAT A PLASTIC BARRIER (DEFECT) INSIDE THE Y CONNECTOR WAS PREVENTING THE DRAINAGE FROM FLOWING. PATIENT PUT OUT 150ML WHEN Y CONNECTOR WAS CHANGED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034629 EQUAL Y CONNECTOR 1/4 ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS KRI NOVOSCI CORP. C320S 303897

    Patients

    Seq Age Sex Outcome Treatment
    1 20440 DA Male