BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFIA 5F 125CM STR

    MDR report key: 15411799 · Received September 13, 2022

    Report

    Report Number
    2032493-2022-00366
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    September 1, 2022
    Report Date
    September 1, 2022
    Manufacturer
    MICROVENTION, INC
    Product Code
    DQY
    UDI-DI
    04987892098499
    PMA / PMN Number
    K131482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE; DQO. A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS DISCARDED AT THE USER FACILITY AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. DEVICE OR PACKAGING IMAGING WAS NOT AVAILABLE. THE WHITE POWDER-LIKE SUBSTANCES FOUND ATTACHED TO THE HUB OF THE MICROCATHETER COULD NOT BE EVALUATED OR VERIFIED.

    Description of Event or Problem · 0

    AS REPORTED; AFTER OPENING THE PACKAGE AND DURING PREPARATION, WHITE POWDER-LIKE SUBSTANCES WERE FOUND TO BE ATTACHED TO THE HUB OF THE MICROCATHETER. THE MICROCATHETER WAS REPLACED WITH A MICROCATHETER FROM A DIFFERENT LOT TO CONTINUE THE PROCEDURE. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. AS THERE WAS NO PATIENT INVOLVEMENT, THERE WAS NO HEALTH DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2533885 SOFIA 5F 125CM STR CATHETER, PERCUTANEOUS DQY MICROVENTION, INC MV-A5125ST 191008563 04987892098499

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown