BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 20ML SILICON-FREE LUER-LOK NORM-JECT

    MDR report key: 7568920 · Received June 4, 2018

    Report

    Report Number
    MW5077639
    Event Type
    Malfunction
    Date Received
    June 4, 2018
    Date of Event
    May 30, 2018
    Report Date
    May 30, 2018
    Manufacturer
    CSL BEHRING, LLC
    Product Code
    FMI
    UDI-DI
    55550000098
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THAT WHEN HE WAS DRAWING UP HIS HAEGARDA, THE SYRINGE STARTED LEAKING. HE PROMPTLY RETURNED THE MEDICATION TO THE VIAL AND USED A DIFFERENT SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408516 SYR 20ML SILICON-FREE LUER-LOK NORM-JECT NEEDLE, HYPODERMIC FMI CSL BEHRING, LLC 17N04C8 55550000098

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR