BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID TESTING NASAL SWABS

    MDR report key: 10982938 · Received December 10, 2020

    Report

    Report Number
    10982938
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 24, 2020
    Report Date
    December 8, 2020
    Manufacturer
    COPAN DIAGNOSTICS, INC.
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UPON PERFORMING DUTIES AT COVID SWAB STATION, WE NOTICED UNOPENED NASAL/COVID SWAB FOR PATIENT AGED 2 AND UNDER WITH VISIBLE BLACK TIP. PACKAGE DID NOT APPEAR TAMPERED WITH AND WAS A CLOSED SYSTEM. EXPIRATION CHECKED WITH LOT: EXP 2023. TOTAL OF 2 SWAB NOTICED WITH BLACK TIP AND PACKAGING AGAIN LOOKED UNTAMPERED WITH, SAME LOT, EXPIRATION. ALL SWABS IN COVID STATION CHECKED, TOOK TO NURSE MANAGER ONSITE, LAB AS WELL, CHARGE NURSE AND COMMUNICATED IN COVID SWABBING CHAT. FOLLOWING INCIDENT AND FOLLOW THROUGH, ALL SWABS WITH SAME LOT PUT OUT OF USE. NO PATIENTS WERE SWABBED DIRECTLY WITH BLACK-TIPPED SWABS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453908 COVID TESTING NASAL SWABS APPLICATOR, ABSORBENT TIPPED, STERILE KXG COPAN DIAGNOSTICS, INC. 2021895

    Patients

    Seq Age Sex Outcome Treatment
    1