BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HIGH VOL. INLET, N/S

    MDR report key: 6418811 · Received March 20, 2017

    Report

    Report Number
    1416980-2017-02448
    Event Type
    Malfunction
    Date Received
    March 20, 2017
    Date of Event
    February 23, 2017
    Report Date
    April 28, 2017
    Manufacturer
    BAXTER HEALTHCARE - ENGLEWOOD
    Product Code
    LHI
    PMA / PMN Number
    K002705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED TWO POTENTIALLY ASSOCIATED LOT NUMBERS, 801901 AND 802085. A BATCH REVIEW WAS CONDUCTED FOR BOTH POTENTIALLY ASSOCIATED LOT NUMBERS, AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF EITHER LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VENTED INLET SET HAD A ¿SOFT PLASTIC OFF-WHITE CYLINDER PARTICULATE¿ ON THE SPIKE OF PORT 1. THIS WAS DISCOVERED AFTER COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199989 VENTED HIGH VOL. INLET, N/S SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - ENGLEWOOD NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1