BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA-FINE INSULIN SYRINGES

    MDR report key: 25137968 · Received May 11, 2026

    Report

    Report Number
    MW5187928
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Report Date
    May 6, 2026
    Manufacturer
    EMBECTA MEDICAL II LLC
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USE AN INJECTABLE MEDICINE AND GET THE COMPOUNDED MEDICINE AND SYRINGES FROM (B)(6) IN (B)(6). I HAVE ALREADY USED 7 SYRINGES FROM A SEALED PACK OF 10 SUPPLIED WHEN TODAY I NOTICED A RED LIQUID INSIDE OF THE NEW SYRINGE WHEN I WENT TO DRAW UP MEDICINE. I CHECKED ONE OF THE REMAINING SYRINGES AND IT SEEMED CLEAR AND THEN ANOTHER AND IT ALSO HAD RED LIQUID INSIDE AND WOULD NOT PULL BACK WITHOUT CAUSING A VACUUM AS IF IT IS BLOCKED. THESE WERE ALL BRAND NEW SYRINGES SUPPLIED BY THE PHARMACY. I NOW WONDER WHAT I HAVE INJECTED INTO MYSELF AS I HAVE HAD MANY FLU/COLD SYMPTOMS AND TIME OFF WORK AS OF LATE AND WONDER IF THIS HAS ANYTHING TO DO WITH IT AS OF COURSE NOTHING HAS BEEN TESTED YET? DEVICE CODE: 2944, 1094. PATIENT CODE: 4582. REFERENCE REPORT MW5187927.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58058 ULTRA-FINE INSULIN SYRINGES SYRINGE, PISTON FMF EMBECTA MEDICAL II LLC 5255125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male PROSTAGLANDIN.| SILDENAFIL.| ZYRTEC.