BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXEL 10-12ML SYR 20GX1" L-L

    MDR report key: 19023036 · Received April 2, 2024

    Report

    Report Number
    1035907-2024-00008
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    October 9, 2020
    Report Date
    March 21, 2024
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    UDI-DI
    20221262544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE CHECKED THE RETAINED SAMPLES AS SOON AS BELOW COMPLAINT WAS RECEIVED, AND NO ABNORMAL WAS FOUND. THIS CAN BE FOUND IN CMP (B)(4).

    Description of Event or Problem · 0

    THE FOLLOWING IS A LEGACY COMPLAINT THAT WAS INVESTIGATED AND CLOSED IN 2020 BUT IS BEING RE-OPENED IN QUALIO BECAUSE THE INCIDENT SHOULD HAVE ORIGINALLY BEEN A REPORTABLE EVENT. REFERENCE CAPA-34 FOR EXPLANATION. WHILE USING THIS BRAND OF NEEDLE SYRINGE COMBO- MULTIPLE PATIENTS EXPERIENCING PHELBITIS- INFLAMMATION OF INJECTION SPOT. THEN NOTICED WHILE DRAWING DIFFERENT INJECTIONS, BLACK PARTICLES FROM THE RUBBER STOPPER IN SYRINGE FLOATING IN SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590033 EXEL 10-12ML SYR 20GX1" L-L SYRINGE WITH NEEDLE FMF EXELINT INTERNATIONAL, CO. 26254 181114 20221262544

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other