BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 TWN

    MDR report key: 21445360 · Received February 24, 2025

    Report

    Report Number
    3024508819-2025-00101
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    February 3, 2025
    Report Date
    March 18, 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

    ADDITIONAL INFORMATION PROVIDED IN B4, G6, H2, H11. CORRECTION MADE TO H6 (INVESTIGATION TYPE, INVESTIGATION FINDING, INVESTIGATION CONCLUSION) 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 UNABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. THE ROOT CAUSE CANNOT BE DETERMINED AS THE ISSUE IS UNCONFIRMED. 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

    13 SYRINGES AFFECTED (10 FROM LOT # 4030016, 3 FROM LOT # 4093019). SEE SECTION C FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    LOT NUMBER 4030016: CUSTOMER COMPLAINED THE SCALE MARKINGS WERE INACCURATE, 1 PACK (10 PCS) IN TOTAL. LOT NUMBER 4093019: CUSTOMER HAD OPENED THE PACKING, COMPLAINED THE SCALE MARKINGS WERE INACCURATE. OPENED 2 PACKS (10 PCS IN ONE PACK) + ONLY 3 PIECES LEFT IN ONE PACK. SAMPLE AVAILABILITY: YES SAMPLE AVAILABILITY DETAILS: PICTURE/VIDEO ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408713 SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 TWN SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328822 4030016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose