BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/4 X 3/8 CONNECTOR

    MDR report key: 12714554 · Received October 28, 2021

    Report

    Report Number
    1718850-2021-00048
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    September 30, 2021
    Report Date
    October 28, 2021
    Manufacturer
    LIVANOVA USA INC
    Product Code
    DTL
    UDI-DI
    00803622129315
    PMA / PMN Number
    EXPEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE WAS NO PATIENT INVOLVEMENT. LIVANOVA USA INC MANUFACTURES THE CONNECTOR. THE INCIDENT OCCURRED IN (B)(6) UNITED STATES OF AMERICA. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE NOT YET RECEIVED.

    Description of Event or Problem · 1

    LIVANOVA USA INC RECEIVED A REPORT THAT A 1/4 X 3/8 CONNECTOR USED TO ATTACH TUBING IN THE CIRCUIT WAS COMPLETELY OCCLUDED. THE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612185 1/4 X 3/8 CONNECTOR CONNECTORS DTL LIVANOVA USA INC Connector 2030100015 00803622129315

    Patients

    Seq Age Sex Outcome Treatment
    1