BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL-MATE RECONSTITUTION DEVICE

    MDR report key: 6069292 · Received November 1, 2016

    Report

    Report Number
    1416980-2016-16841
    Event Type
    Malfunction
    Date Received
    November 1, 2016
    Report Date
    November 23, 2016
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    LHI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION CONNECTED TO A DRUG VIAL AND A BAXTER VIAFLO BAG. VISUAL INSPECTION REVEALED THAT DRUG SOLUTION WAS LEAKING AT THE VIALMATE/VIAL JUNCTION. THE VIALMATE WAS DISASSEMBLED FROM THE DRUG VIAL. VISUAL INSPECTION ON THE DRUG VIAL REVEALED THE PRESENCE OF DENTS ON THE FOIL CAP. AFTER COUPLING THE VIALMATE WITH A NEW DRUG VIAL FREE OF DENTS, FUNCTIONAL LEAK TESTING AND UNDERWATER PRESSURE TESTING WERE PERFORMED WITH NO ISSUES OR LEAKS NOTED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED SOMETIME IN (B)(6) 2016. (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VIALMATE WAS LEAKING DURING TESTING. IT WAS CONNECTED TO A BAG CONTAINING TEST STOCK. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721678 VIAL-MATE RECONSTITUTION DEVICE SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - MALTA NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1