BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1O2¿ VALVE (BLUE) W/CHECK VALVE, ROTATING LUER

    MDR report key: 18796537 · Received February 28, 2024

    Report

    Report Number
    9617594-2024-00202
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    January 12, 2024
    Report Date
    February 28, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K974589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AS THE CUSTOMER HAS DISCARDED IT. WITHOUT THE RETURN OF THE DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED. ADDITIONAL CONTACT INFORMATION LISTING PERMIT HOLDER NAME: BEIJING JASPAR MEDICAL DEVICE CO., LTD (LEGAL REPRESENTATIVE) BEIJING JASPAR MEDICAL DEVICE CO., LTD. ATTN: (B)(6).

    Description of Event or Problem · 0

    THE EVENT INVOLVED THE EVENT INVOLVED A 1O2¿ VALVE (BLUE) W/CHECK VALVE, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE SMART VALVE IS BLOCKED. THE PLACE OF USE IS MEDICAL INSTITUTION. THERE IS NO INFORMATION ABOUT THE PATIENT, THE INFUSION OR THE PROCEDURE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926052 1O2¿ VALVE (BLUE) W/CHECK VALVE, ROTATING LUER SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13527212

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown