BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/4 X 3/8 REDUCING CONNECTOR

    MDR report key: 14453117 · Received May 20, 2022

    Report

    Report Number
    1718850-2022-00038
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Report Date
    July 14, 2022
    Manufacturer
    LIVANOVA USA INC
    Product Code
    DTL
    UDI-DI
    00803622129315
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT ID, AGE OR DOB, SEX, WEIGHT, ETHNICITY: THE WAS NO PATIENT INVOLVEMENT. EVENT DATE IS UNKNOWN. LIVANOVA USA INC MANUFACTURES THE CONNECTOR. THE INCIDENT OCCURRED IN (B)(6). THE INVOLVED DEVICE HAS BEEN RECEIVED AT LIVANOVA ARVADA. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT OF A OCCLUDED CONNECTOR. THE COMPLAINED CONNECTOR WAS RETURNED TO LIVANOVA FOR INVESTIGATION. VISUAL INSPECTION REVEALED THAT THE REDUCER WAS OCCLUDED NEAR THE BASE OF THE 1/4 "END. MOREOVER, THE MATERIAL THAT OCCLUDED THE REDUCER WAS THE SAME AS THE COMPONENT ITSELF. THE DHR REVIEW HIGHLIGHTED THAT THE LOT WHOSE CLAIMED PRODUCT BELONG TO WAS RELEASED AS CONFORM ACCORDING TO SPECIFICATIONS. REVIEW OF THE LIVANOVA COMPLAINT DATABASE IDENTIFIED OTHER THREE SIMILAR EVENTS IN THE LAST YEAR. BASED ON ABOVE, LIVANOVA BELIEVES THE OCCLUSION WAS CAUSED BY A MOLDING DEFECT LIKELY DUE TO A DEFECTIVE SUPPLIED COMPONENT. THE SUPPLIER OF THE COMPONENT WAS FORMALLY INFORMED OF THE ISSUE. INVENTORY STILL PRESENT IN LIVANOVA HAS BEEN DISPOSED AND A NEW ITEM CODE HAS BEEN CREATED IN LIVANOVA. THE RISK IS IN THE ACCEPTABLE REGION. NO OTHER ACTION IS DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.

    Description of Event or Problem · 0

    LIVANOVA USA INC RECEIVED A REPORT THAT CATALOGUE ITEM # EC2140S 1/4X3/8 REDUCING CONNECTOR IS OCCLUDED AND CANNOT FLOW THROUGH IT DURING PRIMING. IN TOTAL OF 3 UNITS ARE AFFECTED HOWEVER ONLY 1 UNIT WILL BE RETURNED. THE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2487845 1/4 X 3/8 REDUCING CONNECTOR CONNECTORS DTL LIVANOVA USA INC CONNECTOR 2023800120 00803622129315

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown