BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS¿ SMARTSITE¿ NEEDLE-FREE VALVE

    MDR report key: 13170722 · Received January 5, 2022

    Report

    Report Number
    9616066-2021-52676
    Event Type
    Malfunction
    Date Received
    January 5, 2022
    Date of Event
    December 7, 2021
    Report Date
    January 21, 2022
    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
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO SAMPLES (MODEL #2000E) WERE RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT THE SMARTSITE WOULD NOT FLUSH. THE SETS WERE EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. THE SAMPLES WERE CONNECTED TO A CUT OFF SYRINGE TIP TO CHECK THAT THE FLUID PATH IS IN AN ACTIVATED POSITION/OPEN WHEN CONNECTED TO A SYRINGE. THE SAMPLES WERE THEN ATTEMPTED TO BE FLUSHED WITH WATER USING A 10ML BD SYRINGE TO CONFIRM AN OPEN FLUID PATH. THE FLUID PATHS OF THE SAMPLES WERE OPEN AND WERE ABLE TO BE FLUSHED. THE FAILURE WAS UNABLE TO BE REPLICATED, AND THE COMPLAINT COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOR MODEL 2000E LOT NUMBER 21095870 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE COULD NOT BE DETERMINED AS NO OCCLUSION OR FLOW RESTRICTION WAS OBSERVED DURING TESTING OF THE RETURNED NEEDLE-FREE CONNECTOR (SMARTSITE). FOLLOWING A SMALL NUMBER OF SIMILAR REPORTS, BD HAS CONDUCTED AN IN-DEPTH INVESTIGATION, CAPA#1998036, TO IDENTIFY ANY POTENTIAL CONTRIBUTING FACTORS FOR OCCLUSION OF THIS NATURE. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FLOW ISSUES - FLUID BLOCKAGE WITH LOT #21095870 REGARDING ITEM #2000E.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ NEEDLE-FREE VALVE WAS BLOCKED DURING THE FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "GMH RADIOLOGY NOTICED SEVERAL TIMES THAT SHE WAS NOT ABLE TO FLUSH THE SMARTSITE VALVE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS¿ SMARTSITE¿ NEEDLE-FREE VALVE WAS BLOCKED DURING THE FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "GMH RADIOLOGY NOTICED SEVERAL TIMES THAT SHE WAS NOT ABLE TO FLUSH THE SMARTSITE VALVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436296 BD ALARIS¿ SMARTSITE¿ NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 21095870

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown