BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO CONVENTIONAL SERIVA CATHETERS

    MDR report key: 22721229 · Received August 5, 2025

    Report

    Report Number
    3012307300-2025-09329
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    January 6, 2025
    Report Date
    August 26, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    CORRECTED: D3 MANUFACTURING PLANT ADDRESS 1, CITY AND ZIP CODE. NO PRODUCT WAS RETURNED. THE REPORTED ISSUE CANNOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. IF THE PRODUCT IS RETURNED, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON PUNCTURING THE PATIENT WITH A NO. 22 AB IN THE LEFT UPPER LIMB (MSE), THE MATERIAL WAS DAMAGED, AS BLOOD WAS LEAKING FROM THE INSERTION SITE, NECESSITATING REMOVAL OF THE VASCULAR ACCESS DEVICE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288230 JELCO CONVENTIONAL SERIVA CATHETERS CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM FOZ ICU MEDICAL, INC. 3027223B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown