BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    NON VENTED HIGH VOL.INLET,N/S

    MDR report key: 8290197 · Received January 30, 2019

    Report

    Report Number
    1416980-2019-00389
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Report Date
    July 26, 2019
    Manufacturer
    BAXTER HEALTHCARE ¿ ROUND LAKE
    Product Code
    LHI
    UDI-DI
    00085412475783
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE: LOT # 802573 AND 802017. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    TWO (2) SINGLE-USE SAMPLES WERE RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NOTED LOOSE FOREIGN MATTER INSIDE OF THE UNOPENED PACKAGING WHICH WAS NOT TOUCHING THE ACTUAL PRODUCT. THE REPORTED ISSUE WAS VERIFIED FOR BOTH RETURNED SAMPLES. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED FOR LOT 802017 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

    ONE SINGLE-USE COMPANION SAMPLE WAS MADE AVAILABLE 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 VERIFIED THE REPORTED ISSUE. 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 LOT 802573 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 FOUR MALFUNCTION EVENTS. IT WAS REPORTED THAT THERE WAS FOREIGN MATTER OBSERVED WITH FOUR (4) NON-VENTED HIGH VOLUME INLETS. IN ONE (1) EVENT, THE FOREIGN MATTER WAS FURTHER DESCRIBED AS OILY/RESIDUE ON THE INLET. IN ONE (1) EVENT, THE FOREIGN MATTER WAS DESCRIBED AS MOISTURE/SLIMY RESIDUE ON THE SPIKE OF THE SET UPON REMOVAL OF THE CAP. IN TWO (2) EVENTS, THE FOREIGN MATTER WAS FURTHER DESCRIBED AS BLACK SPOTS IN THE PACKAGING. 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
    81138 NON VENTED HIGH VOL.INLET,N/S SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE ¿ ROUND LAKE NA SEE H10 00085412475783

    Patients

    Seq Age Sex Outcome Treatment
    1