BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500

    MDR report key: 24562598 · Received March 10, 2026

    Report

    Report Number
    3024508819-2026-00010
    Event Type
    Injury
    Date Received
    March 10, 2026
    Report Date
    March 10, 2026
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    PMA / PMN Number
    K212499
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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 SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    EMAIL COMPLAINT, NEEDLE BREAK, NEEDLE BEND. FROM: SENT: TUESDAY, FEBRUARY 10, 2026, 4:25 AM. TO: PRODUCTCOMPLAINTS <[email protected]>. SUBJECT: INSULIN SYRINGES. TO WHOM IT MAY CONCERN, I HAVE A BOX OF ULTRA-FINE INSULIN SYRINGES U-100 8MM LENGTH NDC 83017-8438-01 31G 3/10 ML. THEY ARE HORRIBLE. NEEDLE BENDS OFTEN WHEN TRYING TO INSERT INTO ABDOMEN. MANY TIMES, NEEDLE BREAKS OFF IN MY SKIN. THEN I LOSE THE ENTIRE DOSE OF INSULIN BECAUSE I CAN'T GET IT OUT OF SYRINGE WITHOUT A NEEDLE! BAD ENOUGH TO HAVE TO USE TWEEZERS TO TRY TO GET NEEDLE OUT. MY LAST SYRINGES WERE B-D. MUCH BETTER QUALITY. THIS SHOULDN'T BE HAPPENING! EVER! (B)(6) 08MARCH2026 - UPDATE/ADDITIONAL INFORMATION FROM (B)(6). THREE ATTEMPTS WERE MADE TO REACH THE CONSUMER REGARDING THE PRODUCT COMPLAINT. AS OF THIS DATE AND TIME, I HAVE NOT HEARD BACK. THERE IS NO ADDITIONAL INFORMATION TO ADD TO THIS FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504423 SYRINGE 0.3ML 31G 8MM WHOLEUNIT 10BG 500 Syringe, piston FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328438 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown