BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEXIUM

    MDR report key: 24641105 · Received March 19, 2026

    Report

    Report Number
    9616066-2026-00714
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 30, 2026
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A DE C.V.
    Product Code
    FMF
    UDI-DI
    10885403221699
    PMA / PMN Number
    K071108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. NO PRODUCT WILL BE RETURNED PER CUSTOMER. NO INVESTIGATION WAS PERFORMED.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.MORE THAN ONE 510K IS APPLICABLE, K231888.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY HAD TO OPEN THREE SYRINGES BEFORE THEY COULD GET ONE THAT WAS FUNCTIONING. THE SYRINGES COULD NOT TRANSFER ANYTHING INTO THE VIALS. DELAY IN COMPOUNDING PROCESS, AS THE TECHNICIAN COULD NOT PULL ANYTHING THROUGH THE SYRINGES, AND IT WAS NOT THE TOPPER, THE TECH FINALLY GOT A GOOD SYRINGE, AND IT WENT FINE. NO PATIENT IMPACTS.

    Description of Event or Problem · 0

    IT WAS REPORTED OCCLUSION WITH TEXIUM. ADDITIONAL INFORMATION. DELAY IN COMPOUNDING PROCESS, THIS SHORT TUBING SET WITH THE TEXIUM ACCESS WOULD NOT LET THE TECHNICIAN PUSH ANY DRUG THROUGH AND THEY HAD TO GET A NEW IV BAG AND TUBING SET TO FINISH THE PREP. NO PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516618 TEXIUM SYRINGE, PISTON FMF SISTEMAS MEDICOS ALARIS S.A DE C.V. 25045036 10885403221699

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown