BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    VENTED MICRO VOL.INLET, N/S

    MDR report key: 8541274 · Received April 23, 2019

    Report

    Report Number
    1416980-2019-02189
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Report Date
    July 26, 2019
    Manufacturer
    BAXTER HEALTHCARE - ROUND LAKE
    Product Code
    LHI
    UDI-DI
    00085412475806
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER # 802495 AND 802479. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THREE SINGLE-USE SAMPLES WERE RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NOTED THAT THE PACKAGING SEAL ON ALL THREE SAMPLES WAS OPENED. THE TOP SEAL WAS OPEN FOR TWO SAMPLES, AND THE BOTTOM SEAL WAS OPEN FOR ONE SAMPLE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED FOR BOTH REPORTED LOT NUMBERS AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF EITHER LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 3 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT THE PACKAGING OF THREE (3) VENTED MICRO-VOLUME INLETS WERE OPENED. THIS WAS OBSERVED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334900 VENTED MICRO VOL.INLET, N/S SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - ROUND LAKE NA SEE H10 00085412475806

    Patients

    Seq Age Sex Outcome Treatment
    1