BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNVIERSAL VIRAL TRANSPORT FOR VIRUSES, CHLAMYDIAE, MYCROPLASMAS, AND UREAPLASMAS

    MDR report key: 20757160 · Received November 22, 2024

    Report

    Report Number
    20757160
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    September 26, 2024
    Report Date
    October 15, 2024
    Manufacturer
    BD
    Product Code
    JSM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    VIRAL TRANSPORT INNER SWAB PACKAGE HAS AN EXPIRATION DATE THAT DOES NOT MATCH OUTER PACKAGE THAT IS SEALED INSIDE OF. UNCLEAR WHICH EXPIRATION DATE TO ADHERE TO. INNER SWAB EXPIRATION [REDACTED DATE], OUTER PACKAGE EXPIRATION DATE [REDACTED DATE]. UNVIERSAL VIRAL TRANSPORT FOR VIRUSES, CHLAMYDIAE, MYCROPLASMAS, AND UREAPLASMAS MFG BD, MFG ITEM NUMBER H192(12), HGT076A, R220529. THE SWAB ON THE RIGHT HAS AN EXPIRATION DATE OF [REDACTED DATE]. NOTIFIED BD, [REDACTED DATE] RESPONDED TO BD INQUIRY UNDER BD CASE NUMBER: (B)(4). MANUFACTURER RESPONSE FOR VIRAL TRANSPORT SWAB, UNVIERSAL VIRAL TRANSPORT FOR VIRUSES, CHLAMYDIAE, MYCROPLASMAS, AND UREAPLASMAS (PER SITE REPORTER). [REDACTED DATE] RESPONDED TO BD INQUIRY UNDER BD CASE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2605019 UNVIERSAL VIRAL TRANSPORT FOR VIRUSES, CHLAMYDIAE, MYCROPLASMAS, AND UREAPLASMAS CULTURE MEDIA, NON-PROPAGATING TRANSPORT JSM BD H192(12), HGT076A R220529

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose