BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE NEEDLE-FREE CONNECTOR

    MDR report key: 12776440 · Received November 9, 2021

    Report

    Report Number
    2243072-2021-02686
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 10, 2021
    Report Date
    November 19, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY TWO 2000E7D SAMPLES BOTH FROM LOT 1021417 WERE RECEIVED IN SEALED PACKAGING FOR INVESTIGATION OF COMPLAINT IN WHICH THE CUSTOMER HAS REPORTED OBSERVING LEAKAGE FROM A 2000E7D SMARTSITE PRODUCT, FROM LOT 1021417. THE CUSTOMER HAS FURTHER STATED THAT THE LEAKAGE OCCURRED IMMEDIATELY AFTER CONNECTING THE SMARTSITE TO A VENFLON PRODUCT, PRIOR TO ANY INFUSION OR DRUG ADMINISTRATION. EXAMINATION OF THE TWO RETURNED 2000E7D PRODUCTS FOUND NO DAMAGE, OR MANUFACTURING DEFECTS WHICH MAY HAVE CONTRIBUTED TO THE CUSTOMER'S EXPERIENCE. NO LEAKAGE WAS OBSERVED DURING PRESSURE TESTING OF THE RETURNED SAMPLES. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION; HOWEVER, IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE IN THIS INSTANCE AS THE AFFECTED PRODUCTS WERE NOT PROVIDED FOR EXAMINATION, AND TESTING OF THE RETURNED UNUSED SAMPLES DID NOT IDENTIFY ANY PRODUCT DEFECTS THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1021417 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 AS THE FEEDBACK WAS NOT REPLICATED, AND THE EXACT NATURE OF THE DEFECT WAS CONFIRMED THERE WAS NOT ENOUGH INFORMATION TO POSITIVELY LINK THIS FEEDBACK TO A SPECIFIC FAILURE MODE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. LOT #: BATCH 1021417 DOES NOT EXIST FOR MATERIAL 2000E7D. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SMARTSITE NEEDLE-FREE CONNECTOR, THE DEVICE EXPERIENCED LEAKAGE TO THE VALVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: AFTER INSERTING A 22G VENFLON , A SMARTSITE NFC WAS ASSEMBLED . ACCORDING TO THE NURSE, SHE SAW BLOOD RETURN AND IT STARTED TO COME OUT OF THE VALVE IMMEDIATELY, PRIOR TO ANY LINE CONNECTION OR FLUSHING. IT HAPPENED SEVERAL TIMES NO USED SAMPLES AVAILABLE (SAMPLES WERE THROWN IN THE TRASH) UNUSED SAMPLES WILL BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SMARTSITE NEEDLE-FREE CONNECTOR, THE DEVICE EXPERIENCED LEAKAGE TO THE VALVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: AFTER INSERTING A 22G VENFLON, A SMARTSITE NFC WAS ASSEMBLED . ACCORDING TO THE NURSE, SHE SAW BLOOD RETURN AND IT STARTED TO COME OUT OF THE VALVE IMMEDIATELY, PRIOR TO ANY LINE CONNECTION OR FLUSHING. IT HAPPENED SEVERAL TIMES NO USED SAMPLES AVAILABLE (SAMPLES WERE THROWN IN THE TRASH) UNUSED SAMPLES WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1676755 BD SMARTSITE NEEDLE-FREE CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown