BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY SYRINGE WITH NEEDLE

    MDR report key: 12293281 · Received August 9, 2021

    Report

    Report Number
    3017368639-2021-00118
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    February 26, 2021
    Report Date
    August 2, 2021
    Manufacturer
    RETRACTABLE TECHNOLOGIES, INC
    Product Code
    MEG
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THIS CUSTOMER REPORTED SEVEN OCCURRENCES OF FOREIGN MATTER WITH LIMITED PRODUCT IDENTIFICATION (LOT NUMBER ONLY). THIS IS TWO OF SEVEN MDRS FILED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT NUMEROUS SYRINGES CONTAIN AN UNEXPLAINED FLUID, VISIBLE IN SOME OF THE SYRINGES BEFORE USE. THE ISSUE WAS IDENTIFIED ACROSS 7 DIFFERENT LOTS. THIS MDR IS SPECIFIC FOR LOT G201024. NO INFORMATION WAS RECEIVED REGARDING ANY SERIOUS INJURY AS A RESULT OF THIS PRODUCT REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191874 SAFETY SYRINGE WITH NEEDLE MEG RETRACTABLE TECHNOLOGIES, INC G201024

    Patients

    Seq Age Sex Outcome Treatment
    1 Other