BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED ICU MEDICAL IV SET

    MDR report key: 20736193 · Received November 20, 2024

    Report

    Report Number
    9617594-2024-01637
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    January 1, 2024
    Report Date
    November 20, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT - THE DATE OF EVENT IS UNKNOWN, AND 01 JAN 2024 HAS BEEN USED AS A PLACEHOLDER. D1 - THE DEVICE INFORMATION WAS NOT PROVIDED. D3 -THE MANUFACTURING LOCATION DEFAULTED TO: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. AVENIDA CUARZO NO. 250, ENSENADA, B.CFA., MEX, 22790. D4 AND H4 THE LOT#, EXPIRATION DATE, AND MANUFACTURE DATE ARE UNKOWN. INVESTIGATION SUMMARY: NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. THE COMPLAINT OF LEAKAGE COULD NOT BE CONFIRMED BY INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED. A LOT HISTORY REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED WITH REGARDS TO AN UNSPECIFIED ICU MEDICAL IV SET THAT EXPERIENCED LEAKAGE. THE REPORTER STATED, ¿LEAK IN B-LINE.¿ SAMPLE IS NOT AVAILABLE FOR RETURN SINCE IT WAS DISCARDED. CUSTOMER RESPONSE IS REQUIRED. NO EVENT INVOLVED DEATH OR SERIOUS DETERIORATION OF A PERSON. THERE WAS PATIENT INVOLVEMENT, THERE WAS UNKNOWN DELAY IN THERAPY, AND NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2447021 UNSPECIFIED ICU MEDICAL IV SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown