BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    VENTED MICRO VOL.INLET, N/S

    MDR report key: 8290731 · Received January 30, 2019

    Report

    Report Number
    1416980-2019-00394
    Event Type
    Malfunction
    Date Received
    January 30, 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 # - 802558, 802546, 802585, AND ONE (1) UNKNOWN LOT NUMBER. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION : ONE SINGLE-USE SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NOTED DARK PARTICULATE MATTER INSIDE AND ATTACHED TO THE INLET TUBING WITHIN THE FLUID PATHWAY. THE TUBING WAS CUT OPEN AND THE PARTICLE EXCISED. THE PARTICLE AND THE INTERIOR SURFACE OF THE TUBING FROM AN ADJACENT LOCATION WERE ANALYZED BY ATTENUATED TOTAL REFLECTANCE (ATR) SPECTROSCOPY. THE ATR SPECTROSCOPY DETERMINED THE SPECTRA OF THE PARTICLE AND THE TUBING LUMEN WERE SIMILAR. THE PARTICLE WAS IDENTIFIED AS POLYVINYL CHLORIDE (PVC). THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE A MANUFACTURING ISSUE. A BATCH REVIEW WAS CONDUCTED FOR LOTS 802546 AND 802585 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.

    Additional Manufacturer Narrative · 1

    ONE SINGLE-USE COMPANION SAMPLE WAS RECEIVED. 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 802558 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 PARTICULATE MATTER OBSERVED WITH FOUR (4) VENTED MICRO-VOLUME INLETS. IN ONE (1) EVENT, THE PARTICULATE MATTER WAS FURTHER DESCRIBED AS OILY/RESIDUE ON THE INLET. IN ONE (1) EVENT, THE PARTICULATE MATTER WAS FURTHER DESCRIBED AS MOISTURE/SLIMY RESIDUE ON THE SPIKE OF THE SET UPON REMOVAL OF THE CAP. IN ONE (1) EVENT, THE PARTICULATE MATTER WAS FURTHER DESCRIBED AS A HAIR INSIDE THE PACKAGING. IN ONE (1) EVENT, THE PARTICULATE MATTER WAS REPORTED TO BE A PARTICLE INSIDE THE SET. 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
    81514 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