BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ VENTED VIAL ADAPTOR

    MDR report key: 15135769 · Received July 29, 2022

    Report

    Report Number
    2243072-2022-01025
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    June 29, 2022
    Report Date
    September 27, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    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

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS YUKON. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 02AUG2022. H6: INVESTIGATION SUMMARY. ONE MV0420-0006 SAMPLE FROM LOT 212049 WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION ATTACHED TO AN EMPTY MEDICATION VIAL (APPENDIX 1). THE CUSTOMER HAS CONFIRMED THAT THE DAMAGE TO THE DEVICE OCCURRED FOLLOWING ATTEMPTED CLINICAL USE. A VISUAL INSPECTION OF THE SAMPLE CONFIRMED THE CUSTOMER EXPERIENCE, AS PART OF A SECTION OF THE VIAL ACCESS DEVICE WHICH INCLUDED ONE OF THE CONNECTING TABS HAD SNAPPED OFF (APPENDIX 2). THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. THIS TYPE OF DAMAGE IS LIKELY TO HAVE OCCURRED AS A RESULT OF THE COMPONENT BEING SUBJECTED TO A AN EXTERNAL FORCE, WHICH CAUSED THE COMPONENT TO BECOME FRACTURED; HOWEVER A DEFINITIVE ROOT CAUSE FOR THIS EXTERNAL FORCE COULD NOT BE DETERMINED IN THIS INSTANCE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 212049 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE QUALITY TEAM AT THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS REPORT IN ORDER TO BE AWARE OF THE REPORTED FEEDBACK DURING FUTURE PRODUCTION OF THIS PRODUCT. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE MV0420-0006 PRODUCT IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LUER-LOK COLLAR ON THE BD SMARTSITE¿ VENTED VIAL ADAPTOR BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "WHEN PIERCING, A PIECE OF THE ADAPTER BROKE OFF AT THE SIDE. ACCORDING TO THE CUSTOMER, THE ADAPTER WAS JUST PIERCED WITH A FINE TWISTING MOTION. NO PATIENT INJURY. NO TREATMENT REQUIRED. NO USER INJURY. NO TREATMENT REQUIRED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LUER-LOK COLLAR ON THE BD SMARTSITE¿ VENTED VIAL ADAPTOR BROKE OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN: "WHEN PIERCING, A PIECE OF THE ADAPTER BROKE OFF AT THE SIDE. ACCORDING TO THE CUSTOMER, THE ADAPTER WAS JUST PIERCED WITH A FINE TWISTING MOTION. NO PATIENT INJURY, NO TREATMENT REQUIRED, NO USER INJURY, NO TREATMENT REQUIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952507 BD SMARTSITE¿ VENTED VIAL ADAPTOR INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 212049

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown