BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 8MM 90 BX 450 MO

    MDR report key: 22158189 · Received June 6, 2025

    Report

    Report Number
    3024508819-2025-00248
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    May 8, 2025
    Report Date
    June 6, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    UDI-DI
    30382903282891
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 0

    HELLO I PURCHASED A BOX OF BD 31G 5/16 1 ML SYRINGES AND HAVE A HARD TIME PUSHING THE PLUNGER. I TRIED WORKING THE PLUNGER PRIOR TO DRAWING FLUID AND IT DOESN¿T HELP I HAVEN¿T HAD THIS PROBLEM WITH OTHER SYRINGE MANUFACTURERS I¿M VERY SURPRISED WITH THIS PRODUCT WHICH IS SUPPOSED TO BE ONE OF THE BEST. I PURCHASED THESE NEEDLES IN JAN 2025 FROM TOTAL DIABETES SUPPLY I¿M PROVIDING PICTURES OF THE BOX WITH VARIOUS NUMBERS. THE PROBLEM I¿M HAVING WITH THE NEEDLES ARE AS FOLLOWS I PRIME THE NEEDLE PRIOR TO USE TO GET THINGS MOVING SMOOTHLY AND THEN INJECT AIR INTO THE VIAL AND THEN DRAW OUT (B)(4) UNITS. I THEN INSERT THE NEEDLE IN VARIOUS PLACES THROUGHOUT THE WEEK AND HAVE PROBLEMS DEPRESSING THE PLUNGER TO INJECT THE LIQUID MEDICATION SO I¿M STUCK WITH THE NEEDLE INSERTED AND CAN¿T GET THE PLUNGER TO DISPENSE THE MEDICATION. NOW I WON¿T USE THE REMAINING NEEDLES DUE TO THESE ISSUES. THIS HAPPENED TWICE LAST WEEK MAY 5-8 2025 AND MANY TIMES PRIOR TO THOSE DATES, I HAVE 60 NEEDLES LEFT INCLUDING THE BOX. I RESEARCHED THE NEEDLE MANUFACTURERS AND BD WAS BEST BUT I¿M SORRY TO SAY I WON¿T BUY BD NEEDLES ANY LONGER. ALL THE NEEDLES I HAVE LEFT ARE UNUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391534 SYRINGE 1.0ML 8MM 90 BX 450 MO Syringe, piston FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328289 4044132 30382903282891

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown