BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEST VIRAL TRANSPORT MEDIA

    MDR report key: 10619322 · Received October 1, 2020

    Report

    Report Number
    MW5097017
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    August 6, 2020
    Report Date
    September 29, 2020
    Manufacturer
    WUXI NEST BIOTECHNOLOGY CO., LTD
    Product Code
    JSM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    NEST VTM WAS RECEIVED BY THE FEDERAL GOVERNMENT VIA THOMAS SCIENTIFIC. I NOTIFIED (B)(6) THE CDC REPRESENTATIVE FOR (B)(6) ON (B)(6) 2020 AND ATTACHED PICTURES OF THE DAMAGED PRODUCT. MY EMAIL IS CUT AND PASTED HERE. "I TOOK SOME PICTURES TODAY OF THE LEAKING REPLACEMENT NEST VTM PRODUCT. I DID NOT HAVE ACCESS TO ALL OF THE PRODUCT ONLY THE BOXES ON TOP OF 4 PALLETS. I RANDOMLY PULLED 5 CARTONS CONTAINING 100 VIALS EACH FROM THE TOP BOXES OF EACH OF THE 4 PALLETS ABOUT 30 CARTONS TOTAL AND I FOUND 25-30% PERCENT WERE LEAKING. IN ADDITION, MANY OF THE CARTONS ARE CRUSHED I CAN'T SEND PRODUCT IN THIS CONDITION TO MY LABS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075726 NEST VIRAL TRANSPORT MEDIA CULTURE MEDIA, NON-PROPAGATING TRANSPORT JSM WUXI NEST BIOTECHNOLOGY CO., LTD 070720MS1

    Patients

    Seq Age Sex Outcome Treatment
    1