BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31G 6MM S/C U-100 RELION

    MDR report key: 19973815 · Received August 13, 2024

    Report

    Report Number
    3024508819-2024-00267
    Event Type
    Malfunction
    Date Received
    August 13, 2024
    Report Date
    July 16, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    UDI-DI
    00681131138369
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (TYPE OF INVESTIGATION AND INVESTIGATION FINDINGS). INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    CONSUMER STATED, "THESE ARE THE WORSE SYRINGES I HAVE EVER USED". STATED, THE NEEDLES ARE PAINFUL WHEN TAKING INJECTIONS. STATED, WHEN SHE SHE DRAWS THE INSULIN, THE INSULIN IS FORCED BACK OUT INTO THE VIAL. SHE DOESN'T UNDERSTAND WHY THE INSULIN WILL NOT STAY IN THE BARREL. STATED, THERE IS NO BRUISING OR BLEEDING FROM THE PAINFUL INJECTIONS. DECLINED REPLACEMENT. LOT: 8100697 CATALOG: 928858 DATE OF EVENT: UNKNOWN SAMPLES: YES CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1093863 SYRINGE 0.5ML 31G 6MM S/C U-100 RELION SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 928858 UNKNOWN 00681131138369

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female