BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    VENTED HIGH VOL. INLET, N/S

    MDR report key: 8290382 · Received January 30, 2019

    Report

    Report Number
    1416980-2019-00390
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Report Date
    April 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 #: 802610, 802616, AND 802615. THE DEVICE WAS RECEIVED FOR TWO (2) EVENTS AND IS CURRENTLY AWAITING EVALUATION. THE DEVICE WAS NOT RECEIVED FOR EVALUATION FOR ONE (1) EVENT; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A BATCH REVIEW WAS CONDUCTED FOR LOT 802615 AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    TWO SINGLE-USE COMPANION SAMPLES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND NOTED A THIN FILM OF SILICONE RESIDUE ON THE SURFACES OF THE SPIKE AND INSIDE SURFACES OF THE CAP. THE SILICONE ON THE INLETS IS NOT CONSIDERED A DEFECT AS MEDICAL GRADE SILICONE OIL IS REQUIRED FOR THESE PRODUCTS FOR PROPER ASSEMBLY AND FUNCTIONALITY AND NO EXCESS SILICONE WAS OBSERVED. A BATCH REVIEW WAS CONDUCTED FOR LOTS 802610 AND 802616 AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES <NOE> 4 </NOE> MALFUNCTION EVENTS. IT WAS REPORTED THAT THERE WAS FOREIGN MATTER IN FOUR (4) VENTED HIGH VOLUME INLETS. IN ONE (1) EVENT, THE FOREIGN MATTER WAS FURTHER DESCRIBED AS OILY/RESIDUE ON THE TIP OF THE INLET. IN THREE (3) EVENTS, THE FOREIGN MATTER WAS FURTHER DESCRIBED AS MOISTURE/SLIMY RESIDUE ON THE SPIKE. THESE EVENTS WERE 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
    81341 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