BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 20343359 · Received October 1, 2024

    Report

    Report Number
    20343359
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    July 16, 2024
    Report Date
    August 13, 2024
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN POURING 0.9% NACL - LOT# G171120, CIRCULATOR NOTICED BLACK DEBRIS FLOATING IN SOLUTION. THE DEBRIS WERE FROM BOVIE PENCIL, NOT SURGICAL PACK. DID NOT REACH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2351708 VALLEYLAB ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI COVIDIEN LP CVPLP2000 G171120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown