BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ VENTED VIAL ADAPTOR

    MDR report key: 16432417 · Received February 23, 2023

    Report

    Report Number
    2243072-2023-00254
    Event Type
    Malfunction
    Date Received
    February 23, 2023
    Date of Event
    January 20, 2023
    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
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUTION?YES. D10: RETURNED TO MANUFACTURER ON: 27-FEB-2023 H6: INVESTIGATION SUMMARY ONE MV0420-0006 SAMPLE WAS RECEIVED FOR INVESTIGATION WITHOUT PACKAGING, HOWEVER THE CUSTOMER INDICATED THAT THE AFFECTED PRODUCT WAS FROM LOT 222081. A VISUAL INSPECTION CONFIRMED THE CUSTOMER'S EXPERIENCE AS THE SMARTSITE WAS OBSERVED TO HAVE BEEN SNAPPED AWAY FROM THE VIAL ACCESS DEVICE (VAD), WITH THE TIP OF THE MALE LUER OF THE SMARTSITE STILL BONDED TO THE VAD. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE COULD NOT BE DETERMINED, HOWEVER PREVIOUS INVESTIGATIONS HAVE CONFIRMED THAT SIMILAR DAMAGE CAN OCCUR AS A RESULT OF A LATERAL FORCE BEING APPLIED TO THE COMPONENT. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 222081 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS YUKON. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE LOT #: 222081 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. EMAIL ADDRESS: (B)(6). 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 THAT DURING USE WITH BD SMARTSITE¿ VENTED VIAL ADAPTOR THERE WAS COMPONENT SEPARATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: ADAPTER IS BROKEN OFF BETWEEN SMART SITE AND ADAPTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD SMARTSITE¿ VENTED VIAL ADAPTOR THERE WAS COMPONENT SEPARATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: ADAPTER IS BROKEN OFF BETWEEN SMART SITE AND ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514947 BD SMARTSITE¿ VENTED VIAL ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 222081 20885403228480

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown