BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCKESSON

    MDR report key: 24958198 · Received April 22, 2026

    Report

    Report Number
    3003674698-2026-01234
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 9, 2026
    Report Date
    April 22, 2026
    Manufacturer
    MEDSOURCE LABS LLC
    Product Code
    FOZ
    UDI-DI
    10612479268583
    PMA / PMN Number
    K161779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THE ITEM WAS LEAKING AT CONNECTION. A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE REPORTED LOT WAS COMPLETED. THE REVIEW DID NOT IDENTIFY ANY DEVIATIONS DURING MAUFACTURING OR TESTING, AND ALL DOCUMENTED PARAMETERS WERE WITHIN THE APPROVED SPECIFICATION LIMITS. THE SAMPLES WERE EVALUATED THROUGH VISUAL INSPECTION AND NO OBERVABLE NON-CONFORMANCES WERE NOTED. SIMULATED TESTING WAS CONDUCTED AND PRODUCT FUNCTIONED AS INTENDED. TESTING CONDUCTED USING THE RETENTION SAMPLES DEMONSTRATED THAT THE PRODUCT DOES NOT EXHIBIT ANY MANUFACTURING DEFECTS. ALL RESULTS WERE FOUND TO BE WITHIN THE SPECIFIED LIMITS, CONFIRMING COMPLIANCE WITH THE PRODUCT'S REQUIREMENTS. POSSIBLE ROOT CAUSES PER THE PRODUCTION TEAM: MANUFACTURING DEFECT: MAY BE DUE TO IMPROPER MOLDING OF 6% TAPER. COMPONENTS MIGHT NOT HAVE BEEN ASSUMBLED ACCURATELY DURING MANUFACTURING. MAY BE DUE TO IMPROPER FITMENT OF THE COMPONENTS. USER ERROR: DEVICE MAY NOT HAVE BEEN HANDLED ACCORDING TO THE MANUFACTURER'S INSTRUCTIONS. MAY BE DUE TO THE THROMBUS FORMATION IN THE BODY OF THE IV CANNULA. MAY BE DUE TO THE MATING PART OF THE OTHER DEVICE NOT BEING PROPER AND IN COMPLIANCE WITH THE INTERNATIONAL STANDARD. BASED ON TESTING RESULTS OF THE SAMPLES, NO NON-CONFORMANCES WERE IDENTIFIED DURING THE EVALUATION OF THE PRODUCT. ALL AVAILABLE INFORMATION AND RECORDS WERE REVIEWED, AND THERE WAS NO EVIDENCE INDICATING A MANUFACTURING, ASSEMBLY, OR FUNCTIONAL DEFECT ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THE ITEM WAS LEAKING AT THE CONNECTION. THIS COULD BE INDICATIVE OF THERE BEING A PUNCTURE THROUGH THE CATHETER WHICH COULD POTENTIALLY LEAD TO SHEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014116 MCKESSON PUSH BUTTON SAFETY IV CATHETER WITH WINGS 22G X 1IN BLUE FOZ MEDSOURCE LABS LLC 200-IVRW221 40897/0527 10612479268583

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown