BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 10907461 · Received November 26, 2020

    Report

    Report Number
    9616066-2020-20447
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    October 26, 2020
    Report Date
    December 9, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A 2000E-04 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER, THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 20075484. ADDITIONAL INFORMATION WAS NOT AVAILABLE TO ASSIST THE INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20075484 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE OF THE REPORTED ISSUE IN THIS INSTANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 ALARIS SMARTSITE NEEDLE-FREE VALVES WERE CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO FLOW OF BLOOD OR FLUID. "BLOCKED" NEEDS A LOT OF FORCE. THE BD SMARTSITE CONNECTORS WE ARE USING HAVE BEEN FAULTY (NOT ALL BUT A LOT OF THEM HAVE). WHEN THE CONNECTOR IS ATTACHED TO THE CANNULA IN THE VEIN YOU ARE UNABLE TO DRAW ANY BLOOD BACK OUT OF IT OR FLUSH ANY SALINE INTO THE CANNULA. IT IS LIKE THERE IS A SEAL IN THE CONNECTOR THAT REQUIRES A LOT OF FORCE TO BREAK AND THE RISK OF DOING THIS WHILE IT IS CONNECTED TO THE CANNULA IS THAT YOU WILL DAMAGE THE VEIN. MULTIPLE STAFF HAVE REPORTED THIS AND THEN I EXPERIENCED IT MYSELF FIRST HAND YESTERDAY WHEN INSERTING A CANNULA.

    Additional Manufacturer Narrative · 1

    2000E-04 THIS IS AN INTERNATIONAL CODE- THE MODEL#/CATALOG# IDENTIFIED IN SECTION D4 IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS 2000E. THE 510K NUMBER PROVIDED IN SECTION G5 IS FOR THE DOMESTIC SIMILAR PRODUCT.- K960280 INITIAL REPORTER ADDR 1: RONALDS TROTTER LEVEL 4 CONNECT BUILDING 585 GREAT SOUTH ROAD A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. FDA DEVICE PROBLEM CODE(S): 1094, 1248. FDA PATIENT PROBLEM CODE(S): 2004.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 10 ALARIS SMARTSITE NEEDLE-FREE VALVES WERE CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO FLOW OF BLOOD OR FLUID. "BLOCKED" NEEDS A LOT OF FORCE. THE BD SMARTSITE CONNECTORS WE ARE USING HAVE BEEN FAULTY (NOT ALL BUT A LOT OF THEM HAVE). WHEN THE CONNECTOR IS ATTACHED TO THE CANNULA IN THE VEIN YOU ARE UNABLE TO DRAW ANY BLOOD BACK OUT OF IT OR FLUSH ANY SALINE INTO THE CANNULA. IT IS LIKE THERE IS A SEAL IN THE CONNECTOR THAT REQUIRES A LOT OF FORCE TO BREAK AND THE RISK OF DOING THIS WHILE IT IS CONNECTED TO THE CANNULA IS THAT YOU WILL DAMAGE THE VEIN. MULTIPLE STAFF HAVE REPORTED THIS AND THEN I EXPERIENCED IT MYSELF FIRST HAND YESTERDAY WHEN INSERTING A CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376637 ALARIS SMARTSITE NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20075484

    Patients

    Seq Age Sex Outcome Treatment
    1