BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDEX ULTRA SMALL BORE EXTENSION SETS

    MDR report key: 13978047 · Received April 1, 2022

    Report

    Report Number
    3012307300-2022-05713
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    January 13, 2022
    Report Date
    March 15, 2023
    Manufacturer
    ST PAUL
    Product Code
    OJA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ADDITIONAL INFORMATION D4 AND G5 ARE UNKNOWN. NO PRODUCT INFORMATION HAS BEEN PROVIDED TO DATE. H3. THIS MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DEVICE HISTORY RECORD REVIEW. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. ONE (1) USED SAMPLE OUTSIDE ITS ORIGINAL PACKAGE WAS RECEIVED. IT WAS CONFIRMED THAT PRODUCT RECEIVED WAS FROM THE PART NUMBER REPORTED. RETURNED DEVICE WAS TESTED FOR WATER LEAK ACCORDING TO PROCEDURE. NO OCCLUSION DEFECT WAS OBSERVED, BUT LEAKAGE CONDITION WAS NOTED AT THE VENT HOLE FILTER. THE BONDING UNIONS OF THE PRODUCT?S COMPONENTS WERE OBSERVED INTACT, NO LACK OR EXCESS OF SOLVENT WERE OBSERVED. A REVIEW OF THE MANUFACTURING PROCESS FOR WAS CONDUCTED BY QUALITY ENGINEER IN ORDER TO VERIFY THAT IF THERE WERE ANY SITUATIONS OR PRACTICES THAT COULD CREATE THE EVENT. NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE THE LEAKAGE FOUND AT THE FILTER AND IT WAS RELATED TO A SUPPLIER ISSUE. A SUPPLIER CORRECTION ACTION REQUEST (SCAR) WAS OPENED FOR FURTHER INVESTIGATION. AWARENESS MEETING WITH OPERATORS AND QUALITY INSPECTORS ABOUT THE FAILURE MODE REPORTED ON THIS COMPLAINT WAS HELD FOR THEIR AWARENESS.

    Description of Event or Problem · 0

    IT WAS REPORTED ON MEDWATCH (B)(4) IV LIPID FILTER NOT ALLOWING LIPIDS TO PASS THROUGH FROM IV TUBING INTO THE FILTER. CHANGED FILTER WITH DIFFERENT LOT NUMBER, AND STILL DID NOT WORK. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837782 MEDEX ULTRA SMALL BORE EXTENSION SETS EXTENSION TUBING SET OJA ST PAUL 4180739

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown