BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ NEEDLE-FREE VALVE

    MDR report key: 15619020 · Received October 17, 2022

    Report

    Report Number
    9616066-2022-01552
    Event Type
    Malfunction
    Date Received
    October 17, 2022
    Date of Event
    September 21, 2022
    Report Date
    November 9, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    H6: INVESTIGATION SUMMARY NO SAMPLES WERE RETURNED FOR INVESTIGATION IN WHICH THE CUSTOMER HAS REPORTED EXPERIENCING OCCLUSION WHEN TRYING TO ADMINISTER MEDICATION THROUGH A 2000E7D SMARTSITE FROM LOT 1023351. DETAILS RELATING TO THE PRODUCT(S) USED TO ACCESS THE 2000E7D WERE NOT PROVIDED TO ASSIST THE INVESTIGATION. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION; HOWEVER, THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE AS NO SAMPLE WAS RECEIVED FOR INVESTIGATION. WITHOUT A SAMPLE TO EXAMINE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1023351 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. IN THIS INSTANCE, A DEFINITIVE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE COULD NOT BE DETERMINED; HOWEVER, PREVIOUS REPORTS OF THIS NATURE HAVE BEEN RELATED TO RAISED FEATURES ON THE SURFACE OF THE MALE LUER OF THE CONNECTING PRODUCT. THESE FEATURES, INCLUDING FLASH OR A RAISED EDGE TO THE TIP OF THE MALE LUER, HAVE PREVIOUSLY BEEN SHOWN TO LEAD TO INTERMITTENT RESTRICTED FLOW DUE TO PINCHING OF THE BLUE PISTON OF THE SMARTSITE WHICH SUBSEQUENTLY DOES NOT ALLOW IT TO OPEN FULLY. THIS CAN SOMETIMES BE RESOLVED BY DISCONNECTING AND REATTACHING THE SAME LUER CONNECTION WHICH MAY REPOSITION THE LUER AGAINST THE PISTON AND IMPROVE THE FLOW, OR ALTERNATIVELY BY CHANGING THE CONNECTING MALE LUER. THE CONNECTING PRODUCT IN CLINICAL USE AT THE TIME OF THE CUSTOMER'S EXPERIENCE WAS NOT RECEIVED FOR INVESTIGATION; THEREFORE, IT WAS NOT POSSIBLE TO CONFIRM IF THE CONNECTING PRODUCT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ NEEDLE-FREE VALVE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEVICES WERE BLOCKED, BUT THE BLOCKAGE COULD BE CLEARED BY APPLYING SOME EXTRA PRESSURE ON THE SYRINGE PLUNGER AND AFTER THAT THE DEVICE FUNCTIONED NORMALLY. AS THE CUSTOMER IS PREPARING SMALL QUANTITIES OF EXPENSIVE SUBSTANCES IT IS NOT POSSIBLE FOR THEM TO CLEAR ANY BLOCKAGE BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ NEEDLE-FREE VALVE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DEVICES WERE BLOCKED, BUT THE BLOCKAGE COULD BE CLEARED BY APPLYING SOME EXTRA PRESSURE ON THE SYRINGE PLUNGER AND AFTER THAT THE DEVICE FUNCTIONED NORMALLY. AS THE CUSTOMER IS PREPARING SMALL QUANTITIES OF EXPENSIVE SUBSTANCES IT IS NOT POSSIBLE FOR THEM TO CLEAR ANY BLOCKAGE BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2932098 BD SMARTSITE¿ NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 1023351

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown