BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUEST PBS (PHOSPHATE BUFFERED SALINE) NP SWAB COVID- 19 NASAL SWAB TEST

    MDR report key: 10239079 · Received July 6, 2020

    Report

    Report Number
    MW5095376
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 1, 2020
    Manufacturer
    UNK
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MEDICAL PROVIDER WAS TESTING PARTICIPANT FOR COVID-19 (USING A QUEST PBS PHOSPHATE BUFFERED SALINE NP SWAB) THAT WAS PLACED IN THE NARES. BEFORE PROVIDER COULD SPIN SWAB, IT BROKE IN PARTICIPANT'S NOSE. PROVIDER WAS UNABLE TO REMOVE IT FROM POSTERIOR ASPECT OF NOSE. IT SUBSEQUENTLY ENDED UP IN THE PHARYNX WHERE SHE SWALLOWED IT. SHE DID NOT HAVE ANY DIFFICULTY SWALLOWING. LABONE INC SUBSIDIARY OF QUEST DIAGNOSTICS, (B)(4). US. KIT LOT # I5MU4-04/14/2021. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695298 QUEST PBS (PHOSPHATE BUFFERED SALINE) NP SWAB COVID- 19 NASAL SWAB TEST APPLICATOR, ABSORBENT TIPPED, STERILE KXG UNK SWAB LOT#041520B01

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other