BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY SYRINGE WITH NEEDLE

    MDR report key: 12292985 · Received August 9, 2021

    Report

    Report Number
    3017368639-2021-00052
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    January 19, 2021
    Report Date
    July 23, 2021
    Product Code
    MEG
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MCKESSON MEDICAL SURGICAL IS THE ASSEMBLER OF THE ANCILLARY CONVENIENCE KIT TO SUPPORT THE U.S. GOVERNMENT'S COVID-19 VACCINATION PROGRAM. WE PREVIOUSLY REPORTED THIS EVENT TO BOTH (B)(4) BUT RECOGNIZE DUE TO A RETROSPECTIVE REVIEW THAT THIS EVENT SHOULD HAVE ALSO BEEN REPORTED AS AN MDR TO FDA. AS PART OF OUR CONTINUOUS IMPROVEMENT GOALS WE ARE PROVIDING THIS MDR FOR REVIEW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DURING A PATIENT'S SECOND VACCINE DOSE, THE PERSON ADMINISTERING THE VACCINE REMOVED THE NEEDLE AND HALF CAME OUT. PATIENT WOULD LIKE TO KNOW WHETHER SHE NEEDS TO DO A RE-DOSE SINCE SHE DOESN'T FEEL SHE RECEIVED A FULL DOSE SINCE SO MUCH CAME RUNNING OUT.. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT MALFUNCTION. THIS COMPLAINT WAS INITIALLY REPORTED TO PFIZER AND PFIZER FORWARDED TO MCKESSON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192077 SAFETY SYRINGE WITH NEEDLE MEG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other