BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL-MATE RECONSTITUTION DEVICE

    MDR report key: 13205935 · Received January 10, 2022

    Report

    Report Number
    1416980-2021-07782
    Event Type
    Malfunction
    Date Received
    January 10, 2022
    Date of Event
    December 16, 2021
    Report Date
    March 18, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    LHI
    PMA / PMN Number
    K142600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    B5: UPDATE "A VIAL-MATE ADAPTER HAD INFUSED WITHOUT BEING ACTIVATED" TO "THAT AN UNSPECIFIED SOLUTION BAG INFUSED WITHOUT THE ATTACHED VIAL-MATE ADAPTER BEING ACTIVATED". F10/H6: MEDICAL DEVICE PROBLEM CODES: REPLACE A140502 WITH A1501. THE ACTIVATION ISSUE WITH THE VIAL-MATE ADAPTER WOULD RESULT IN A DELAY OF DELIVERY. A DELAY OF DELIVERY IS NOT LIKELY TO CAUSE A DEATH OR SERIOUS INJURY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A VIAL-MATE ADAPTER HAD INFUSED WITHOUT BEING ACTIVATED. THE ISSUE WAS IDENTIFIED DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983694 VIAL-MATE RECONSTITUTION DEVICE SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED SMALL VOLUME BAG