BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMOSAFELOCK CONNECTER

    MDR report key: 21610131 · Received March 14, 2025

    Report

    Report Number
    9617594-2025-00481
    Event Type
    Malfunction
    Date Received
    March 14, 2025
    Date of Event
    December 25, 2024
    Report Date
    March 14, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K081361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A COUPLE OF PHOTOS WERE SHARED BY THE CUSTOMER. WHERE A SYRINGE IS CONNECTED TO A CHEMOSAFE LOCK WITH A SPINNING MECHANISM, BASED ON KL-MNU3 CONFIGURATION THIS SHOULDN¿T HAVE A SPINNING MECHANISM. NO ADDITIONAL DAMAGE OR ANOMALIES ARE OBSERVED. ONE (1) OPENED/UNUSED LIST# KL-MNU3, CHEMOSAFELOCK CONNECTER WAS RETURNED FOR EVALUATION. AS RECEIVED A SPINNING MECHANISM WAS CONFIRMED ON THE RETURNED SET. BASED ON THE ITEM CONFIGURATION OF #KL-MNU3, THESE SAMPLES SHOULDN'T HAVE A SPINNING MECHANISM. NO ADDITIONAL DAMAGE OR ANOMALIES ARE OBSERVED. THE COMPLAINT OF LABELING DOES NOT AGREE WITH THE TYPE OF PRODUCT AND CAN BE CONFIRMED BASED ON THE RETURNED SAMPLE EVIDENCE. THE PROBABLE CAUSE WAS DUE TO A MIXING ERROR DURING THE PACKAGING PROCESS AT ENSENADA. THE LOT HISTORY WAS REVIEWED, AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CHEMOSAFELOCK CONNECTER WAS FOUND TO HAVE BEEN MISLABELED. THE REPORTER STATED "EVENT: PRODUCT MIX-UP SUSPECTED. A KL-MSU3 MAY HAVE BEEN PACKED IN THE UNIT BOX OF KL-MNU". USE OF ACTUAL SAMPLE WAS BEFORE USE TO THE PATIENT. THE SET WAS NOT CONTAMINATED WITH BLOOD OR BODY FLUID. THERE WAS NO REPORTED IMPACT OF THE EVENT ON THE PATIENT AND MEDICAL INSTITUTION WORKER. THE REPORTER STATED "COMPLAINT: PRODUCT MIX-UP -ONE(1) ACTUAL SAMPLE WAS RECEIVED CONNECTED TO A TERUMO SYRINGE(30ML). -SPINNING FUNCTION EXISTS IN THE SAMPLE THAT EVIDENT THE SAMPLE IS APPARENTLY KL-MSU3". THE EVENT WAS NOTED DURING PREPARATION AND WAS DETECTED PRIOR TO DIRECT PATIENT USE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641897 CHEMOSAFELOCK CONNECTER SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13998357

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown