BEUDAMED
    FDA Adverse Event Other Summary report: N

    VIAL MATE ADAPTER

    MDR report key: 17836539 · Received September 27, 2023

    Report

    Report Number
    MW5146249
    Event Type
    Other
    Date Received
    September 27, 2023
    Report Date
    September 27, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS IS AN EMAIL RECEIVED FROM XXXXXX MEMORIAL AND FELLOW INVOLVEMENT WITH THEIR MSO CALLS. IT HAS TO DO WITH DEVICE MALFUNCTION REPORTING (LEAKING) OF + VIALMATE ADAPTERS INTENDED TO PERMIT ADMIXTURE ON DEMAND. SUBMITTING ON THEIR BEHALF. MANUFACTURER: AUROMEDICS I AM WAITING TO HEAR BACK FROM THEM ABOUT THEIR REVIEW OF THE PRODUCT I SENT BACK TO THEM. VIAL DOES NOT REACH THE BAG APPROPRIATELY WHEN ATTACHED TO A VIALMATE ADAPTER. THE NURSE DOES THEIR PART TO CONNECT THEN THE BAG LEAKS SLOWLY AROUND THE VIAL. PRODUCT: AZITHROMYCIN 500 MG (NDC55150-174-10). + VIALMATE ADAPTER LOT: MULTIPLE LOTS KNOWN TO BE AFFECTED (PLUS REPORTED TO HAPPEN AT ANOTHER SITE WITH INVANZ VIALS FROM SAME MANUFACTURER). (B)(6) SUBMISSION ID 87516. SUBMITTED DATE 08/07/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002819 VIAL MATE ADAPTER SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION MAM23006 3AM22038

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown