BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN INC

    MDR report key: 24625509 · Received March 18, 2026

    Report

    Report Number
    3003560965-2026-00004
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    March 5, 2026
    Report Date
    March 16, 2026
    Manufacturer
    ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD.
    Product Code
    FMI
    UDI-DI
    00304040003091
    PMA / PMN Number
    K112057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON CUSTOMER FEEDBACK AND A REVIEW OF RELEVANT LITERATURE BY OUR COMPANY, IN VITRO STUDIES HAVE FOUND THAT SIGNIFICANT CRYSTALLIZATION OCCURS WITH VARIOUS CLINICALLY COMMON MIXED REGIMENS.METHYLPREDNISOLONE USED FOR INTRA-ARTICULAR INJECTION IS USUALLY A SUSPENSION (E.G., METHYLPREDNISOLONE ACETATE), IN WHICH THE DRUG IS SUSPENDED IN LIQUID AS MICROCRYSTALS RATHER THAN BEING COMPLETELY DISSOLVED. WHEN SUCH A SUSPENSION IS MIXED WITH OTHER DRUGS,ESPECIALLY THOSE WITH COMPLEX COMPOSITIONS,ITS PHYSICAL STABILITY MAY BE COMPROMISED, CAUSING MICROCRYSTALS TO AGGREGATE INTO VISIBLE PRECIPITATES OR FLOCS, WHICH CAN RESULT IN NEEDLE BLOCKAGE.IN ADDITION, ALTHOUGH DEXAMETHASONE IS GENERALLY A SOLUTION AND RELATIVELY STABLE, STUDIES HAVE SHOWN THAT IT MAY ALSO REACT OR FORM PRECIPITATES WHEN MIXED WITH OTHER DRUGS. CASES OF THIS COMPLIANT ASSOCIATED WITH THE MIXING OF DEXAMETHASONE AND OTHER DRUGS HAVE BEEN DOCUMENTED IN THE LITERATURE.BASED ON THE ABOVE INVESTIGATION, THIS COMPLAINT WAS CAUSED BY THE PHYSICAL AND CHEMICAL INCOMPATIBILITY BETWEEN THE MIXED DRUGS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS THAT WHILE USING EITHER THE 30GA NEEDLE(HS (B)(6)) THEY WERE CLOGGING WHEN MIXING DIFFERENT TYPES OF DRUGS. THESE INCLUDED DEXAMETHASONE, METHYLPREDNISOLONE, MARCAINE AND LIDOCAINE. THIS WAS FOR JOINT INJECTIONS, PLANTAR FASCIA. THE AMOUNTS WOULD BE EITHER OF THE FOLLOWING: A. 2CC LIDOCAINE, .5CC DEXAMETHASONE, .5CC METHYLPREDNISOLONE, B. 2CC MARCAINE, .5CC DEXAMETHASONE, .5CC METHYLPREDNISOLONE, C. 1CC MARCAINE, .25CC DEXAMETHASONE, .25CC METHYLPREDNISOLONE. THIS HAPPENED WITH MULTIPLE PATIENTS OVER THE LAST MONTH, NO SPECIFICS WOULD BE PROVIDED. NO PATIENTS WERE HARMED OR REQUIRED ANY MEDICAL ATTENTION. THERE WAS A DELAY AS THEY HAD TO USE THREE DIFFERENT NEEDLES ON THEIR PATIENTS, WITH MULTIPLE PATIENT OCCURRING WITH MULTIPLE DOCTORS IN THEIR PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147759 HENRY SCHEIN INC HYPODERMIC NEEDLES FMI ZHEJIANG KINDLY MEDICAL DEVICES CO., LTD. 30G*11" 20241120 00304040003091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown