BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE NEEDLE-FREE CONNECTOR

    MDR report key: 10848612 · Received November 16, 2020

    Report

    Report Number
    9616066-2020-20343
    Event Type
    Malfunction
    Date Received
    November 16, 2020
    Date of Event
    October 22, 2020
    Report Date
    November 17, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    07613203011938
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: (B)(6) 2020. H.6. INVESTIGATION: ONE 2000E-04 SAMPLE FROM LOT 20075177, WAS RECEIVED FOR INVESTIGATION IN OPENED PACKAGING; MARKS FROM RESIDUAL FLUID WERE PRESENT ON THE SAMPLE. A VISUAL INSPECTION OF THE 2000E-04 SAMPLE DID NOT IDENTIFY ANY SIGNS OF DAMAGE OR MANUFACTURING DEFECTS WHICH COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. THE SAMPLE WAS CONNECTED TO A 50 ML BD PLASTIPAK SYRINGE FROM RETAINED STOCK AND FLUSHED WITH FLUID; NO OCCLUSION OR FLOW RESTRICTIONS WERE IDENTIFIED DURING TESTING. FURTHERMORE, PRESSURE FLUID WAS APPLIED FROM THE MALE LUER COMPONENT; NO LEAKAGE OR FURTHER ISSUES WERE IDENTIFIED. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20075177, DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SMARTSITE NEEDLE-FREE CONNECTOR WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE 'BUNG' DOES NOT FUNCTION PROPERLY, THAT IS, IT DOES NOT FLUSH. WE HAVE HAD QUITE A FEW DO THIS SO IT IS NOT A ONE-OFF EVENT.

    Additional Manufacturer Narrative · 1

    2000E-04 THIS IS AN INTERNATIONAL CODE- THE MODEL#/CATALOG# IDENTIFIED 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 IS FOR THE DOMESTIC SIMILAR PRODUCT.-K960280. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SMARTSITE NEEDLE-FREE CONNECTOR WAS CLOGGED/BLOCKED/OCCLUDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE 'BUNG' DOES NOT FUNCTION PROPERLY, THAT IS, IT DOES NOT FLUSH. WE HAVE HAD QUITE A FEW DO THIS SO IT IS NOT A ONE-OFF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314347 SMARTSITE NEEDLE-FREE CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20075177 07613203011938

    Patients

    Seq Age Sex Outcome Treatment
    1