BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAB

    MDR report key: 10205848 · Received June 26, 2020

    Report

    Report Number
    MW5095247
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    June 17, 2020
    Report Date
    June 24, 2020
    Manufacturer
    COPAN DIAGNOSTICS, INC.
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD COVID-19 SWAB ORDERED. RN WENT TO OBTAIN COVID-19 SPECIMEN VIA NASOPHARYNGEAL SWAB. WHILE RN WAS SWABBING PATIENT; THE TIP OF THE COVID-19 SWAB BROKE OFF PRIOR TO THE RN REMOVING SWAB. CCM CRNP ATTEMPTED TO REMOVE SWAB FROM PATIENT'S R NARE USING NASAL SPUTUM KIT AND WAS UNSUCCESSFUL. PATIENT REQUIRED BRONCHOSCOPY AND DR. WAS ABLE TO REMOVE FRACTURED NASOPHARYNGEAL SWAB. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667894 SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG COPAN DIAGNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR