BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROCLAVE® CLEAR CONNECTOR

    MDR report key: 15936268 · Received December 7, 2022

    Report

    Report Number
    9617594-2022-00318
    Event Type
    Malfunction
    Date Received
    December 7, 2022
    Date of Event
    November 8, 2022
    Report Date
    November 10, 2022
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619042509
    PMA / PMN Number
    K970855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SISTER DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN B5 CONFIRMING A VOID OF MFR # 9617594-2022-00318-00.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MICROCLAVE CLEAR CONNECTOR LEAKED FLUOROURACIL (5FU). THE PATIENT WAS COMING BACK FOR A 5FU SUREFUSER DISCONNECT. THE NEEDLESS CONNECTOR WAS SECURED WHEN CHECKED BY THE NURSING STAFF AND WAS NOT OVER-TIGHTENED. THERE WERE NO OBVIOUS CRACKS OR DEFORMITIES NOTED WITH THE BUNGS. THE CLINICIAN BELIEVES THE BUNGS WERE FROM THE SAME BATCH AS THEY WERE IN ALL THE TROLLEYS WHEN A CHECK OF THE STOCK WAS PERFORMED. THE PATIENT WENT HOME WITH ELASTOMERIC. THE PATIENT WAS REPORTED TO HAVE HAD SLIGHT SKIN IRRITATION AND WAS TREATED WITH MOISTURIZER, WHEN THE NURSE SAW THE PATIENT AGAIN IN A COUPLE OF DAYS THE IRRITATION HAD SETTLED. THERE WAS NO CHEMO SPILL, JUST CRYSTALLIZATION OF CHEMO AT THE SITE OF CONNECTION AND SOME ON THE PATIENT¿S SKIN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT TWO OF TWO.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS PROVIDED, BY THE CUSTOMER, STATING THERE WAS ONLY 1 OCCURRENCE AND 1 PATIENT WHICH IS CAPTURED IN 9617594-2022-00317-01.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444495 MICROCLAVE® CLEAR CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 011-MC100 6032274 00840619042509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown FLUOROURACIL, UKN MFR| SUREFUSER FROM NIPRO