BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN INC

    MDR report key: 24631250 · Received March 18, 2026

    Report

    Report Number
    3003560965-2026-00005
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 26, 2026
    Report Date
    March 16, 2026
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
    Product Code
    FMI
    UDI-DI
    00304040002940
    PMA / PMN Number
    K112057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO CUSTOMER FEEDBACK AND OUR LITERATURE REVIEW, KENALOG IS A SUSPENSION RATHER THAN A FULLY DISSOLVED SOLUTION. THIS MEANS THE PRODUCT CONTAINS FINE PARTICLES. IF THE DRUG IS NOT ADEQUATELY SHAKEN BEFORE USE, THE DRUG PARTICLES WILL SETTLE AND AGGREGATE AT THE BOTTOM OF THE VIAL. DURING ASPIRATION, THESE AGGREGATED LARGE PARTICLES ENTER THE SYRINGE AND CAN EASILY CAUSE NEEDLE BLOCKAGE. LIDOCAINE AND MARCAINE ARE GENERALLY COMPATIBLE. HOWEVER, WHEN KENALOG IS MIXED WITH THEM, IMPROPER MIXING ORDER OR PROLONGED STANDING AFTER MIXING MAY CAUSE KENALOG PARTICLES TO FLOCCULATE DUE TO MINOR CHANGES IN OSMOTIC PRESSURE OR PH, FORMING LARGER CLUMPS AND RESULTING IN SYRINGE BLOCKAGE. IN ADDITION, THE INJECTION SITES ARE CONCENTRATED IN DENSE CONNECTIVE TISSUE AREAS SUCH AS THE ANKLE, INTERMETATARSAL SPACE, AND NEUROMA, WHICH INHERENTLY HAVE HIGH RESISTANCE. WHEN THE DRUG CONTAINS SUSPENDED PARTICLES, THE PARTICLES ARE MORE LIKELY TO BE COMPRESSED AND ACCUMULATED AT THE NEEDLE BEVEL AS THE NEEDLE PASSES THROUGH DENSE TISSUE, CREATING A WEDGING EFFECT THAT LEADS TO BLOCKAGE. BASED ON THE ABOVE INVESTIGATION, THIS COMPLAINT WAS MOST LIKELY CAUSED BY DRUG PARTICLES OR PARTICLES/FLOCS FORMED AFTER MIXING, RESULTING IN SYRINGE/NEEDLE BLOCKAGE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT EVERY SINGLE ONE THEY USE IS GETTING CLOGGED. THEY USE KENALOG, LIDOCAINE AND MARCAINE. IT HAPPENED TO 14 OF THE PATIENTS WITH TWO DIFFERENT DOCTORS. ALL OF THE PROCEDURES ARE ON THE FEET, ANKLE, INTERSPACSM, NUEROMA, HEEL TRIGGER POINTS AND SINUS TARSI INJECTIONS.NO PATIENTS WERE HARMED OR REQUIRED ANY MEDICAL ATTENTION. IT HAPPENED ON (B)(6) 2026. NO PATIENT SPECIFICS PROVIDED. NO PHOTOS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601508 HENRY SCHEIN INC HYPODERMIC NEEDLES FMI ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 27G*1 1/4'' 20250721 00304040002940

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown