BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 30GA 8MM 10BAG 500CAS AP

    MDR report key: 21911017 · Received April 25, 2025

    Report

    Report Number
    3024508819-2025-00203
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Report Date
    May 22, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. NO DEFINITIVE ROOT CAUSE DETERMINED 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 IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    PRODUCT ISSUE: 1) 03 EA BLUR LOT & 01 EA TORN , 06 EA GOOD ); 2) 01 EA TORN , 19 EA GOODS , 02 EA BOX GLUE; 3) 50 EA TORN. PRODUCT QUANTITY: 1) 1, 2) 2, 3) 5. TMAIK (B)(6) 2025. AS PER ATTACHED INFORMATION: 328838, SYRIN 0.3ML 30GA 8MM 10BAG 500CAS SYRINGE, 03 EA BLUR LOT & 01 EA TORN , 06 EA GOOD). 1. 03 EA BLUR LOT & 01 EA TORN , 06 EA GOOD ), 4198008. 328838, SYRIN 0.3ML 30GA 8MM 10BAG 500CAS SYRINGE, 01 EA TORN , 19 EA GOODS , 02 EA BOX GLUE. 2. 01 EA TORN , 19 EA GOODS , 02 EA BOX GLUE, 4191027. 328838, SYRIN 0.3ML 30GA 8MM 10BAG 500CAS SYRINGE, 50 EA TORN. 5. 50 EA TORN, 4191027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347123 SYRINGE 0.3ML 30GA 8MM 10BAG 500CAS AP SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328838 4198008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown