BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMOLOCK W/RED CAP

    MDR report key: 11793863 · Received May 7, 2021

    Report

    Report Number
    9617594-2021-00150
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 14, 2021
    Report Date
    April 15, 2021
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    UDI-DI
    00887709091887
    PMA / PMN Number
    K131549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE NEW LIST# CL2000S-RC, CHEMOLOCK¿ W/RED CAP (LOT# 5131546) AND THREE NEW LIST# CL2100, CHEMOLOCK¿ PORTS (LOT# 5054143) WERE PROVIDED AND VISUALLY INSPECTED. AS RECEIVED, NO VISIBLE DAMAGE OR ANOMALIES WERE IDENTIFIED. NO USED PRODUCT WAS RETURNED. DRY DISCONNECT TESTING WAS PERFORMED ON ALL FOUR CHEMOLOCK SAMPLES USING RED DYED WATER. ALL CHEMOLOCK SAMPLES MET THE TESTING EXPECTATIONS OUTLINED IN THE PRODUCT PERFORMANCE SPECIFICATION. ALTHOUGH RED WATER CAN BE SEEN WITHIN THE FLUID PATH OF THE CHEMOLOCKS, NO FLUID DROPLETS WERE NOTED ON THE DISCONNECTED DEVICES. THE REPORTED COMPLAINT COULD NOT BE REPLICATED OR CONFIRMED. A DEVICE HISTORY REVIEW (DHR) LOT# 5168244 AND RELEVANT COMMODITIES WERE REVIEWED, AND NO NON-CONFORMANCES WERE FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A CHEMOLOCK® W/RED CAP THAT THE CUSTOMER REPORTED THE NURSE HAD JUST FINISHED HER INTRAVENOUS (IV) PUSH OF ADRIAMYCIN AND UPON DISCONNECTING SHE OBSERVED A DROP OF RED ON CL2100. THE NURSE USED THE ALCOHOL SWAB TO WIPE THE DROP OFF AND DISCARDED THE DEVICE. THE DEVICE REPLACED WITH ANOTHER WITHOUT AN ISSUE. THERE WAS NO REPORT OF HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688970 CHEMOLOCK W/RED CAP CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5168244 00887709091887

    Patients

    Seq Age Sex Outcome Treatment
    1