BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG

    MDR report key: 22318631 · Received June 24, 2025

    Report

    Report Number
    3024508819-2025-00257
    Event Type
    Malfunction
    Date Received
    June 24, 2025
    Report Date
    September 3, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH SUBMISSION IS BOTH AN INITIAL AND SUPPLEMENTAL FILING. INVESTIGATION OF THE RESULTS CAN BE SEEN BELOW: 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

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (TYPE OF INVESTIGATION). INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. 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 NOT 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    LOT: 4142017. CATALOG: 324910. PRODUCT IS BEING USED "OFF LABEL" NO REPLACEMENTS. ON THU, MAY 29 3:06 PM. I HOPE THIS MESSAGE FINDS YOU WELL. I AM REACHING OUT TO EXPRESS A CONCERN REGARDING THE QUALITY OF A RECENT BATCH OF SYRINGES WE PURCHASED, WHICH WE REGULARLY USE FOR BOTOX INJECTIONS IN OUR MEDICAL PRACTICE. WHILE WE¿VE ALWAYS TRUSTED BD FOR RELIABLE MEDICAL SUPPLIES, WE¿VE UNFORTUNATELY EXPERIENCED A NOTICEABLE DECLINE IN NEEDLE QUALITY WITH THIS PARTICULAR BATCH. SEVERAL OF OUR PATIENTS HAVE REPORTED INCREASED PAIN DURING THEIR BOTOX TREATMENTS, WHICH WE HAVE TRACED BACK TO THE SYRINGES. UPON INSPECTION, IT APPEARS THAT THE NEEDLES MAY BE DULL, WHICH COULD BE CONTRIBUTING TO THE DISCOMFORT EXPERIENCED DURING INJECTIONS. THIS IS A SIGNIFICANT ISSUE FOR BOTH OUR PATIENTS¿ EXPERIENCE AND THE STANDARDS OF CARE WE AIM TO UPHOLD. WE INITIALLY CONTACTED OUR SUPPLIER REGARDING THIS MATTER, AND THEY ADVISED US TO REACH OUT TO BD DIRECTLY. WE WOULD APPRECIATE YOUR ASSISTANCE IN ADDRESSING THIS CONCERN AND DETERMINING HOW BEST TO PROCEED¿WHETHER THAT INVOLVES INVESTIGATING THE BATCH, ISSUING A REPLACEMENT, OR PROVIDING ADDITIONAL SUPPORT. I HAVE ATTACHED PHOTOS OF THE BOX OF SYRINGES AND THE LOT NUMBER. PLEASE LET US KNOW WHAT INFORMATION YOU MAY NEED FROM US TO MOVE FORWARD. WE LOOK FORWARD TO YOUR PROMPT RESPONSE AND RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654215 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 324910 4142017 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown