BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAVE¿ NEUTRAL CONNECTOR

    MDR report key: 20846133 · Received December 4, 2024

    Report

    Report Number
    9617594-2024-01731
    Event Type
    Malfunction
    Date Received
    December 4, 2024
    Date of Event
    November 1, 2024
    Report Date
    January 23, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619045593
    PMA / PMN Number
    K100434
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION- THE INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 0

    RECEIVED THE FOLLOWING: ONE (1) USED LIST# B3300, CLAVE¿ NEUTRAL CONNECTOR; LOT# 14029184. ONE (1) USED LIST# UNKNOWN, CATHETER; LOT# UNKNOWN. TWO (2) NEW LIST# B3300, CLAVE¿ NEUTRAL CONNECTOR; LOT# 14029184. TWO (2) NEW LIST# UNKNOWN, BD INSYTE AUTOGUARD 24 GA X 0.75 IN; LOT# 4080062. TWO (2) NEW LIST# UNKNOWN, BD INSYTE AUTOGUARD 22 GA X 1.00 IN; LOT# 4101330. NO DAMAGES OR ANOMALIES WERE OBSERVED ON ANY OF THE SAMPLES. THE REPORTED COMPLAINT OF A LEAK COULD NOT BE CONFIRMED. THE CATHETERS AND MALE LUERS WERE FOUND TO BE ISO COMPLIANT, EASILY REMOVED, AND NO LEAKS WERE OBSERVED DURING TESTING ON THE USED OR NEW SAMPLES. THE LOT HISTORY WAS REVIEWED, NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNKNOWN DATE INVOLVING A CLAVE¿ NEUTRAL CONNECTOR WHERE THE REPORTER STATED THAT THERE WAS LEAKING (BLOOD AND OR FLUIDS) AT THE CONNECTION BETWEEN THE IV CATHETER AND THE BLUE CLAVE. ADDITIONALLY, THE CUSTOMER STATED THAT THE PROBLEM WAS USING THE BD INSYTE AUTOGUARD WITH THE ICU MEDICAL B3300. THE LEAK WAS TAKING PLACE RIGHT AT THE CONNECTION OF BOTH ONCE TWISTED TOGETHER. THE CUSTOMER ALSO STATED THAT IT WAS VERY DIFFICULT TO TURN (TWIST) THE B3300 INTO THE AUTOGUARD THREADS AND ONCE IN, IT IS ALMOST IMPOSSIBLE TO REMOVE IT LIKE IT IS STUCK. THEY ARE FINDING COMPLAINTS IN CANCER CARE WITH CHEMO LEAKING. DUE TO PATIENT SAFETY, THEY CANNOT USE THE 60 CASES DUE TO THIS SERIOUS PROBLEM. THERE WAS UNKNOWN PATIENT INVOLVEMENT BUT NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941465 CLAVE¿ NEUTRAL CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14029184 00840619045593

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown