BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 31GA 8MM TW 10BAG 500 TWN

    MDR report key: 20224085 · Received September 16, 2024

    Report

    Report Number
    3024508819-2024-00331
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Report Date
    June 26, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED TO SECTIONS B4, G6, H2, H3, AND H11. CORRECTIONS MADE TO SECTIONS D3 (COUNTRY TYPE & COUNTRY) AND H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, & INVESTIGATION CONCLUSIONS). INVESTIGATION SUMMARY: NO PHYSICAL SAMPLES WERE RECEIVED HOWEVER THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO(S) PROVIDED. THIS IS THE 1ST 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. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. 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 SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H11. INVESTIGATION SUMMARY: ADDITIONAL INFORMATION RECEIVED, SITUATION ANALYSIS EMBC-25-0002-SA WAS OPENED TO ADDRESS THIS COMPLAINT.

    Description of Event or Problem · 0

    THE STOCK CODES LISTED IN THE TABLE BELOW WERE FOUND WITH TWO DIFFERENT STOCK MIXES IN THECARTON UPON REDRESSING. THE TWO UNITS OF STOCK WERE FOUND IN TWO DIFFERENT CARTONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100942 SYRINGE 1.0ML 31GA 8MM TW 10BAG 500 TWN SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328820 3142087

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown