BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGYLE FLEXIBLE YANKAUER

    MDR report key: 17568852 · Received August 17, 2023

    Report

    Report Number
    9612030-2023-03803
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Report Date
    August 18, 2023
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS RECEIVED VIA AN ANONYMOUS CLINICAL STUDY. SAMPLE ANALYSIS COULD NOT BE PERFORMED SINCE SAMPLES WERE NOT PROVIDED FOR EVALUATION. THIS COMPLAINT WILL BE USED FOR TRENDING AND POST MARKET ANALYSIS.

    Additional Manufacturer Narrative · 0

    SEE SECTION D (SUSPECT MEDICAL DEVICE): D1 (BRAND NAME): ORIGINALLY REPORTED AS UNKNOWN OPERATING ROOM AND SHOULD BE ARGYLE FLEXIBLE YANKAUER. D2A (PRODUCT CODE) ORIGINALLY REPORTED AS JOL AND SHOULD BE GCX. D2B (COMMON DEVICE NAME): ORIGINALLY REPORTED AS CATHETER AND TIP, SUCTION AND SHOULD BE APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED.

    Description of Event or Problem · 0

    PER A POST MARKET CLINICAL SURVEY, THE CUSTOMER OBSERVED THAT THE DEVICE BREAKS DURING USE RESULTING IN A SHARP TIP OR SHARP TIP OUT OF PACKAGE WITH THE USE OF AN ARGYLE YANKAUER FLEXIBLE SUCTION DEVICE. THIS INFORMATION WAS RECEIVED VIA AN ANONYMOUS POST MARKET CLINICAL STUDY; THEREFORE, THE CUSTOMER INFORMATION IS UNKNOWN AND NO FURTHER INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1280665 ARGYLE FLEXIBLE YANKAUER APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX CARDINAL HEALTH UNKNOWN OPERATING ROOM
    1665362 ARGYLE FLEXIBLE YANKAUER APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX CARDINAL HEALTH UNKNOWN OPERATING ROOM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown