BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NDL, GRIPPER MICRO, 22G X .75", LUER ACTIVATED NEEDLELESS Y-SITE

    MDR report key: 22962814 · Received September 4, 2025

    Report

    Report Number
    3012307300-2025-10321
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    June 1, 2025
    Report Date
    September 4, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586029882
    PMA / PMN Number
    K072059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 9617604-2025-00233-00. THE DATE OF THAT SUBMISSION WAS 04-JUL-2025. H3: ONE USED SAMPLE WAS RECEIVED FOR ANALYSIS. VISUAL INSPECTION WAS PERFORMED, AND THE INSERTER WAS SEEN TO BE PLACED 180 DEGREES FROM ITS CORRECT ORIENTATION ON THE INFUSION SITE. NO OTHER DAMAGE OR ANOMALIES WERE OBSERVED. TO REPLICATE CLINICAL USE, THE SAMPLE WAS PREPARED FOR USE AS PER IFU. THE INSERTER WAS ORIENTED CORRECTLY ON THE INFUSION SITE. THE SAMPLE WAS THEN FLUSHED, INSERTED AND REMOVED FROM THE INJECTION SITE. THE NEEDLE ON THE SAFETY MECHANISM ENGAGED WITHIN THE INSERTER. NO DIFFICULTIES WERE OBSERVED DURING USE. THE COMPLAINT OF DIFFICULTY TO REMOVE CANNOT BE CONFIRMED NOR REPLICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE IS HARD TO REMOVE WHEN THE SAFETY FUNCTION IS ACTIVATED, SO CUSTOMER USED OTHER PRODUCTS. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2255742 NDL, GRIPPER MICRO, 22G X .75", LUER ACTIVATED NEEDLELESS Y-SITE SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6070870 10610586029882

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown