BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE NEEDLE-FREE CONNECTOR

    MDR report key: 11091442 · Received December 29, 2020

    Report

    Report Number
    9616066-2020-20673
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    November 30, 2020
    Report Date
    January 14, 2021
    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
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10/D11: CONCOMITANT MEDICAL PRODUCTS: DEVICE AVAILABLE FOR EVAL YES. D10/D11: CONCOMITANT MEDICAL PRODUCTS: RETURNED TO MANUFACTURER ON: 2020-12-23. H6: INVESTIGATION SUMMARY: TWO 2000E-04 SAMPLES WERE RECEIVED FOR INVESTIGATION WITH AN OPENED PACKAGING FROM LOT 20065103. ADDITIONALLY A 10ML BD SYRINGE WITH RESIDUAL FLUID WAS RECEIVED CONNECTED TO ONE OF THE SAMPLES TO ASSIST THE INVESTIGATION. A VISUAL INSPECTION OF THE SAMPLES DID NOT IDENTIFY ANY SIGNS OF DAMAGE OR MANUFACTURING DEFECTS WHICH COULD HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. FUNCTIONAL TESTING WAS PERFORMED BY SEPARATELY CONNECTING EACH SAMPLE TO THE RECEIVED 10ML SYRINGE AND FLUSHING WITH FLUID; NO FLOW RESTRICTION OR OCCLUSION WAS OBSERVED THROUGHOUT TESTING. THE TEST WAS THEN REPEATED USING A 50ML BD PLASTIPAK SYRINGE FROM STOCK AGAIN NO FLOW RESTRICTIONS OR OCCLUSIONS WERE OBSERVED. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20065103 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. TESTING OF THE RETURNED SAMPLE DID NOT IDENTIFY ANY PRODUCT DEFECTS OR QUALITY DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT REPORTS OF THIS NATURE AGAINST THE STANDALONE SMARTSITE DEVICE OCCUR AT A LOW FREQUENCY AND HAVE NOT BEEN ATTRIBUTABLE TO A PRODUCT DEFECT OR MANUFACTURING ISSUE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SALINE WOULD NOT FLUSH THROUGH THE SMARTSITE NEEDLE-FREE CONNECTOR WHEN CONNECTED WITH THE SYRINGE. THIS OCCURRED 5 SEPARATE TIMES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SMARTSITE CONNECTED TO LUER-OCK SYRINGE WITH SALINE BUT WOULD NOT FLUSH. THIS HAS OCCURRED ON 4 OTHER OCCASIONS THIS WEEK."

    Additional Manufacturer Narrative · 1

    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 SALINE WOULD NOT FLUSH THROUGH THE SMARTSITE NEEDLE-FREE CONNECTOR WHEN CONNECTED WITH THE SYRINGE. THIS OCCURRED 5 SEPARATE TIMES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SMARTSITE CONNECTED TO LUER-OCK SYRINGE WITH SALINE BUT WOULD NOT FLUSH. THIS HAS OCCURRED ON 4 OTHER OCCASIONS THIS WEEK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552150 SMARTSITE NEEDLE-FREE CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20065103

    Patients

    Seq Age Sex Outcome Treatment
    1