BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE¿ VENTED VIAL ACCESS DEVICE

    MDR report key: 16261214 · Received January 28, 2023

    Report

    Report Number
    2243072-2023-00084
    Event Type
    Malfunction
    Date Received
    January 28, 2023
    Date of Event
    December 16, 2022
    Report Date
    March 7, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    UDI-DI
    20885403228480
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. (B)(4). MEDICAL DEVICE LOT #: 222081 WAS REPORTED, HOWEVER, THIS IS NOT A LOT # MANUFACTURED FOR THE REPORTED CATALOG #. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: AN MV0420-0006 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 222081. AS PART OF THE INVESTIGATION, THE CUSTOMER PROVIDED A PHOTOGRAPH OF THE AFFECTED SAMPLE TO ASSIST THE INVESTIGATION; ANALYSIS OF THE PHOTOGRAPH CONFIRMED THE CUSTOMER'S EXPERIENCE WITH THE FEMALE LUER ADAPTER (FLA) OF THE SMARTSITE APPEARING TO HAVE SEPARATED FROM THE CLEAR BODY OF THE SMARTSITE. HOWEVER NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION IN THIS INSTANCE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 222081 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING SMARTSITE¿ VENTED VIAL ACCESS DEVICE THE COMPONENTS SEPARATED. THIS OCCURRED 3 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: DURING THE BLOOD SAMPLING, THE SMATSITE VALVE ATTACHED TO A LUER SYRINGE DETACHED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING SMARTSITE¿ VENTED VIAL ACCESS DEVICE THE COMPONENTS SEPARATED. THIS OCCURRED 3 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: DURING THE BLOOD SAMPLING, THE SMATSITE VALVE ATTACHED TO A LUER SYRINGE DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372091 SMARTSITE¿ VENTED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN 20885403228480

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown