BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20770618 · Received November 25, 2024

    Report

    Report Number
    20770618
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    October 15, 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

    THE INNER PACKAGE IS A LATER EXPIRATION DATE THAN THE OUTER PACKAGE WHICH IS DIFFERENT THAN THE FIRST REPORT BUT STILL A DISCREPANCY. THE BOX THE SWABS CAME IN (QUANTITY (B)(4)) HAS THE EXP OF [REDACTED DATE]. OUTER PACKAGE H192: LOT #N30494500 (B)(6) EXP: [REDACTED DATE]. INNER PACKAGE R220531: LOT #N302783 (B)(6) EXP: [REDACTED DATE]. THIS IS THE SECOND BATCH OF PRODUCTS WE HAVE FOUND, DIFFERENT LOT NUMBERS, DIFFERENT EXPIRATION DATES. SEE REPORT [REDACTED NUMBER]. ESCALATED TO BD AGAIN TODAY. NO RECALLS LISTED IN ONERECALL. MANUFACTURER RESPONSE FOR VIRAL SWAB, UNIVERSAL VIRAL TRANSPORT FOR VIRUSES, CHLAMYDIAE, MYCROPLASMAS, AND UREAPLASMAS (PER SITE REPORTER) ON [REDACTED DATE] AND AGAIN TODAY WHEN ADDITIONAL PRODUCT FOUND WITH OTHER LOT/EXPIRATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2256963 UNVIERSAL VIRAL TRANSPORT FOR VIRUSES, CHLAMYDIAE, MYCROPLASMAS, AND UREAPLASMAS CULTURE MEDIA, NON-PROPAGATING TRANSPORT JSM BD H192 N30494500, N302783

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose