BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA

    MDR report key: 21789257 · Received April 7, 2025

    Report

    Report Number
    3024508819-2025-00167
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 13, 2025
    Report Date
    April 7, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH REPORT IS BOTH AN INITIAL AND FINAL SUBMISSION AS THE INVESTIGATION HAS BEEN COMPLETED. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 2ND COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. 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.

    Description of Event or Problem · 0

    I USED A SYRINGE WITH PROBLEM YESTERDAY (B)(6) 2025. WHEN I WENT TO PRESS THE INSULIN, THE SYRINGE DID NOT PUSH THE INSULIN. LOT 3325073 C 2024 01-02 2028 - 12-31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658587 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAGSLA Syringe, piston FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 324916 3325073

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown