BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARALAST

    MDR report key: 25089156 · Received May 5, 2026

    Report

    Report Number
    2032282-2026-00080
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Report Date
    May 5, 2026
    Manufacturer
    TAKEDA PHARMACEUTICALS U.S.A.,INC.
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS SUBMITTED FOLLOWING A RETROSPECTIVE COMPLAINT REVIEW CONDUCTED UNDER CAPA PR 5560509. THE EVENT MET MDR REPORTABILITY CRITERIA BUT WAS NOT REPORTED WITHIN THE REQUIRED TIMEFRAME DUE TO AN INITIAL MISASSESSMENT OF REPORTABILITY. THIS REPORT IS BEING SUBMITTED UPON IDENTIFICATION OF THE REPORTING GAP AND CONFIRMATION OF REPORTABILITY. THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION AND NO PHOTOS PROVIDED. REPORTED DEFECT CANNOT BE VERIFIED. REVIEW OF INCOMING GOOD RELEASE DOCUMENTATION OF BATCH 1161567, ITEM NUMBER 3400164/ TRANSFERNADEL 20GX1 1/2 SIL., SHOWED THAT THERE WERE NO NONCONFORMITIES, FAILURES, REWORK OR DEVIATIONS THAT CONTRIBUTED TO THE REPORTED PROBLEM. ALL INCOMING RELEASE RESULTS AND PARAMETERS MET SPECIFICATIONS. REVIEW OF INCOMING GOOD RELEASE DOCUMENTATION OF BATCH 1170572, ITEM NUMBER 3400465/ FILTERSPIKE 20 MICRON, SHOWED THAT THERE WERE NO NONCONFORMITIES, FAILURES, REWORK OR DEVIATIONS THAT CONTRIBUTED TO THE REPORTED PROBLEM. ALL INCOMING RELEASE RESULTS AND PARAMETERS MET SPECIFICATIONS. A REVIEW OF THE MONTHLY REPORT ((B)(6) 2024) FOR ARALAST WAS ALSO PERFORMED RELATIVE TO THE SUBCATEGORY "PRODUCT PARTICLES". THE COMPLAINT RATE FOR 2024 IS APPROXIMATELY (B)(4). THERE IS NO COMPLAINT RATE FOR 2022 / 2023. D2B PROCODE: THE FDA EMDR SYSTEM REQUIRES SELECTION OF A PRODUCT CODE; THEREFORE, PRODUCT CODE LHI WAS SELECTED. ARALAST DOES NOT HAVE AN INDEPENDENT FDA DEVICE PRODUCT CODE.

    Description of Event or Problem · 0

    ON TUESDAY (B)(6) 2024 AN HCP CONTACTED MEDICAL INFORMATION WITH A ARALAST NP QUESTION. THE HCP'S QUESTION HAS BEEN RESPONDED TO, BUT DURING OUR CONVERSATION HE REPORTED THE FOLLOWING PC INFORMATION. THE FACILITY USED THE SUPPLIED 20 MICRON FILTER NEEDLE AFTER RECONSTITUTION TO INJECT MEDICATION INTO BAG BUT PULLED THE MEDICATION OUT WITH REGULAR NEEDLE (INSTEAD OF FILTER NEEDLE), THEN ATTACHED FILTER AND PUSHED INTO BAG. INSTEAD OF ATTACHING THE FILTER NEEDLE TO THE SYRINGE AND WITHDRAWING THE MEDICATION FROM THE BAG. IT WAS NOTED AFTER RECONSTITUTING THE MEDICATION AS DESCRIBED ABOVE THAT WERE PARTICLES INSIDE FINAL BAG OF MEDICATION. AVAILABLE FOR RETURN: NO. ADDITIONAL IDENTIFYING INFORMATION: PC FILED DUE TO REPORT OF "PARTICLES" NOTED AFTER PRODUCT WAS FILTERED AND RECONSTITUTED. HCP MADE THE DECISION TO CONTACT MI AFTER NOTICING PARTICLES IN BAG. MEDICATION WAS NOT ADMINISTERED TO ANY PATIENT. MEDICATION DOSE, LOT NUMBER, EXPIRATION, AND NDC NUMBER WERE NOT REPORTED. CONSENT TO CONTACT REPORTER? NO. DOSE NUMBER / UNIT: 0. DOSAGE FORM: VIAL. FOLLOW-UP TO A PREVIOUS COMPLAINT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259146 ARALAST Set, i.V. Fluid transfer LHI TAKEDA PHARMACEUTICALS U.S.A.,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown