BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    VENTED HIGH VOL. INLET, N/S

    MDR report key: 8541582 · Received April 23, 2019

    Report

    Report Number
    1416980-2019-02195
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Report Date
    July 29, 2019
    Manufacturer
    BAXTER HEALTHCARE - ROUND LAKE
    Product Code
    LHI
    UDI-DI
    00085412475790
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBERS: 802485 AND 802607. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    TWO SINGLE-USE DEVICES WERE RECEIVED FOR EVALUATION. FOR THE FIRST DEVICE, VISUAL INSPECTION REVEALED LOOSE PARTICULATE MATTER INSIDE THE STERILE PACKAGE. THE PARTICULATE MATTER APPEARS TO BE A HAIR APPROXIMATELY 0.50 INCHES IN LENGTH ON THE INSIDE OF THE SEALED PACKAGING. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE A MANUFACTURING ISSUE. FOR THE SECOND DEVICE, VISUAL INSPECTION WAS PERFORMED AND NOTED A LOOSE HAIR INSIDE OF THE PACKAGING, NOT TOUCHING THE DEVICE. THE REPORTED ISSUE WAS VERIFIED. THE CAUSE OF THE CONDITION WAS NOT DETERMINED. A BATCH REVIEW WAS CONDUCTED FOR LOTS 802485 AND 802607 AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THESE LOTS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 2 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT THERE WAS A HAIR INSIDE THE PACKAGING OF TWO (2) VENTED HIGH-VOLUME INLETS. THIS WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335075 VENTED HIGH VOL. INLET, N/S SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - ROUND LAKE NA SEE H10 00085412475790

    Patients

    Seq Age Sex Outcome Treatment
    1