BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRUS TRANSPORT MEDIUM WITH SWAB

    MDR report key: 12083844 · Received June 29, 2021

    Report

    Report Number
    12083844
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    August 11, 2020
    Report Date
    June 18, 2021
    Manufacturer
    HARDY DIAGNOSTICS
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RN ATTEMPTED TO OBTAIN COVID-19 POLYMERASE CHAIN REACTION (PCR) PER ORDER. SWAB INSERTED THROUGH LEFT NARE. AFTER REMOVING FROM NARE, SWAB NOT INTACT. TIP OF THE SWAB WAS NOT ABLE TO BE SEEN IN THE PATIENT'S NARE. CERTIFIED CASE MANAGER (CCM) CONTACTED. PLANS TO CONSULT ENT. SPECIMEN ABLE TO BE OBTAINED FROM RIGHT NARE WITH A NEW SWAB. CENTRAL ITEM # (B)(4) "VIRUS TRANSPORT MEDIUM WITH SWAB FOR THE COLLECTION AND TRANSPORTATION OF VIRUS SPECIMENS" LOT #: 20200515. MFG #: 20200515. PER CONSULTATION NOTE: "ENT CONSULTED FOR COVID SWAB BROKEN OFF IN NOSE. PATIENT INTUBATED IN THE ICU WITH POSITIVE COVID. CHART REVIEWED. PATIENT NON-RESPONSIVE DURING EXAMINATION AND RETRIEVAL OF SWAB. ENDOSCOPE USED TO VIEW THE LEFT NASAL CAVITY. ALLIGATOR FORCEPS USED TO REMOVE THE SWAB. NG (NASOGASTRIC) TUBE SECURED IN RIGHT NASAL CAVITY. NO OTHER LESIONS NOTED OF NASAL CAVITIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982461 VIRUS TRANSPORT MEDIUM WITH SWAB APPLICATOR, ABSORBENT TIPPED, STERILE KXG HARDY DIAGNOSTICS 20200515

    Patients

    Seq Age Sex Outcome Treatment
    1 20440 DA