BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESWAB

    MDR report key: 10219204 · Received July 1, 2020

    Report

    Report Number
    3002444944-2020-00006
    Event Type
    Injury
    Date Received
    July 1, 2020
    Report Date
    June 2, 2020
    Manufacturer
    COPAN ITALIA SPA
    Product Code
    JTW
    PMA / PMN Number
    K061301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE THE COMPANY'S ATTEMPTS TO OBTAIN THE LOT NUMBER INVOLVED IN THE INCIDENT BOTH THROUGH DIRECT CONTACT WITH THE INITIAL REPORTER AND THROUGH THE LOCAL DISTRIBUTOR, NO INFORMATION WAS RETRIEVED. DUE TO THE MISSING LOT # AND ADDITIONAL INFORMATION ON THE EVENT, IT WAS NOT POSSIBLE TO COMPLETE THE INTERNAL INVESTIGATION. THE ANALYSIS OF HISTORICAL DATA DID NOT SHOW OTHER SIMILAR CASE. THIS IS THE FIRST NOTIFICATION RECEIVED OF THIS TYPE.

    Description of Event or Problem · 1

    A REPORT WAS SENT BY THE INITIAL REPORTER TO FDA THROUGH THE MEDWATCH PROGRAM (REPORT#MW5094613). COPAN DIAGNOSTICS, AS COPAN (B)(4) US AGENT, BECAME AWARE OF THE EVENT ON 06/02/2020. THE REPORT WAS RECEIVED IN THE MAILBOX AS FIRST AND SOLE NOTIFICATION OF THE EVENT. THE DESCRIPTION OF THE EVENT WAS AS FOLLOWS: "SEVERE PROLONGED BLEEDING GRATER THAN 1 HOUR FROM COVID 19 TESTING USING COPAN ESWAB 480C WHITE CAP VIA NASOPHARYNGEAL ROUTE". THE LOT# WAS NOT AVAILABLE. THE SAME DAY, COPAN CONTACTED THE INITIAL REPORTER (NURSE) BY EMAIL ASKING FOR LOT# AND THE FACILITY. THE NURSE ANSWERED THAT SHE DID NOT HAVE THE LOT NUMBER, THAT THE FACILITY WAS (B)(6) AND THAT THE FACILITY WAS PROVIDED WITH THE COPAN ESWAB 480C. THE NURSE WAS TOLD BY (B)(6) LABS THAT "THIS WAS APPROVED BY THE FDA FOR NASOPHARYNGEAL TESTING BUT SHE THOUGH THAT THE FDA STATES IT IS OROPHARYNGEAL ONLY". THE NURSE WAS THE PERSON THAT HAD SEVERE BLEEDING. ON 06/10/2020 COPAN CONTACTED AGAIN THE NURSE BY EMAIL ASKING FOR ADDITIONAL INFORMATION ON (B)(6) LAB AND SENDING A QUESTIONNAIRE TO FURTHER INVESTIGATE THE EVENT. ON THE 06/15/2020 THE NURSE CONFIRMED THAT "(B)(6) IS THE LABORATORY THAT SUPPLIES (B)(6) WITH THE SUPPLIES FOR TESTING AND RUNS THE TESTS". SHE TOLD THAT "(B)(6) LAB HAD PERMISSION FROM THE FDA TO USE 480C OROPHARYNGEAL KIT FOR TESTING WITH THE NASOPHARYNGEAL ROUTE". SHE CONFIRMED THAT SHE WAS TESTED BY ANOTHER HEALTHCARE PROFESSIONAL (IT WAS NOT A SELF-COLLECTION). NO INFORMATION ON LOT# OR COMPLETED QUESTIONNAIRE WAS PROVIDED. COPAN MADE 4 ADDITIONAL ATTEMPTS (ON THE 15TH JUN, 17TH JUN, ON 23RD JUN, ON 30TH JUN) BY EMAIL TO OBTAIN MISSING INFORMATION. NO ADDITIONAL INFORMATION WAS RECEIVED TILL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685101 ESWAB COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM JTW COPAN ITALIA SPA 480C

    Patients

    Seq Age Sex Outcome Treatment
    1