BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML 30G 8MM CENTRAL EURO

    MDR report key: 21159781 · Received January 15, 2025

    Report

    Report Number
    3024508819-2025-00040
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Report Date
    March 16, 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 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 AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    HI XXX, WE DO NOT HAVE ANY PURCHASING INFORMATION. WE RECEIVED THE PRODUCT COMPLAINT (PC) (B)(4). REPORTING FROM A PARTICLE IN A BD ADMINISTRATION SYRINGE. WE PROVIDED THE BD SYRINGE THE VOXZOGO COMBINATION PRODUCT PACK. DOES OUR QTA ACCOMMODATE A PRODUCT COMPLAINT INVESTIGATION BY BD, AT OUR REQUEST? IF NOT, HOW DO WE INITIATE THE BD INVESTIGATION? THANK YOU FOR YOUR HELP. THANKS, (B)(6). HELLO XXX, HI (B)(6), WE RECEIVED A PRODUCT COMPLAINT OF A YELLOW SUBSTANCE/PARTICLE IN A VOXZOGO BD ADMINISTRATION SYRINGE AND NEED TO REQUEST AN INVESTIGATION WITH BD. FROM THE PHOTOGRAPH AND VIDEO PROVIDED, THE SUBSTANCE/PARTICLE IS VISIBLE AND LOOKS TO BE TOO LARGE TO BE TRANSFERRED THROUGH THE 30G NEEDLE. THEREFORE, THE REPORTED SUBSTANCE/PARTICLE ORIGINATED IN THE SYRINGE. THE SYRINGE IS NOT AVAILABLE FOR RETURN, DUE TO THE CUSTOMS REGULATIONS IN CHINA. THE BD LOT IS 2241039. COULD YOU PLEASE INITIATE AN INVESTIGATION WITH BD FOR THIS SYRINGE LOT? PLEASE SEE THE ATTACHED FILES FOR VIDEO AND PHOTOS OF THE REPORTED SUBSTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364655 SYRINGE 1ML 30G 8MM CENTRAL EURO SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 320935 / 32093540 2241039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown