BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE

    MDR report key: 15831439 · Received November 20, 2022

    Report

    Report Number
    2243072-2022-02003
    Event Type
    Malfunction
    Date Received
    November 20, 2022
    Date of Event
    September 30, 2022
    Report Date
    November 30, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    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 #: AN INVALID LOT # OF 222047 WAS PROVIDED BY THE INITIAL REPORTER. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 21-OCT-2022. H.6. INVESTIGATION SUMMARY: ONE MV0420-0006 SAMPLE WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION, THERE WAS NO RESIDUAL FLUID IN THE DEVICE. A VISUAL INSPECTION OF THE RETURNED MV0420-0006 SAMPLE CONFIRMED THE CUSTOMER'S EXPERIENCE AS THE SMARTSITE COMPONENT COULD BE EASILY SEPARATED FROM THE VIAL ACCESS DEVICE, STRESS MARKS WERE VISIBLE AT THE MALE LUER OF THE SMARTSITE AND THE CONNECTING FEMALE LUER OF THE VIAL ACCESS DEVICE WAS BROKEN. 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 OF SMARTSITE SEPARATION COULD NOT BE DETERMINED IN THIS INSTANCE, HOWEVER PREVIOUS INVESTIGATIONS HAVE CONFIRMED THAT THE OBSERVED DAMAGE TO THE VIAL ACCESS DEVICE CAN OCCUR AS A RESULT OF A LATERAL FORCE BEING APPLIED TO THE COMPONENT WHEN CONNECTED TO A SYRINGE. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 222047 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. 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 SET IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO BD SMARTSITE¿ VENTED VIAL ACCESS DEVICES EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CHEMOTHERAPY DRUG PREPARATION OPERATOR INSERTED THE SPIKE INTO THE CARBOPLATIN CHEMOTHERAPY DRUG BOTTLE. AFTER CONNECTING THE TEXIUM OF THE SYRINGE TO DRAW THE DRUG, HE NOTICED A LOSS OF DRUG (WITH CONSEQUENT SPILLAGE) DUE TO THE PRESENCE OF A CRACK AT THE CONNECTION POINT BETWEEN THE SMART-SITE AND THE GREEN PART. A FEW DAYS AGO, A SIMILAR EVENT HAD OCCURRED WITH THE SAME BATCH SPIKE, BUT IN THE PREVIOUS CASE THE SMART-SITE HAD DETACHED COMPLETELY. BOTH EVENTS OCCURRED INSIDE THE ISOLATOR AND DID NOT INVOLVE PATIENTS. IN BOTH CASES, SPILLAGE OF CHEMOTHERAPEUTIC DRUG AND BREAKDOWN OF STERILITY OF THE PREPARATION OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO BD SMARTSITE¿ VENTED VIAL ACCESS DEVICES EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CHEMOTHERAPY DRUG PREPARATION OPERATOR INSERTED THE SPIKE INTO THE CARBOPLATIN CHEMOTHERAPY DRUG BOTTLE. AFTER CONNECTING THE TEXIUM OF THE SYRINGE TO DRAW THE DRUG, HE NOTICED A LOSS OF DRUG (WITH CONSEQUENT SPILLAGE) DUE TO THE PRESENCE OF A CRACK AT THE CONNECTION POINT BETWEEN THE SMART-SITE AND THE GREEN PART. A FEW DAYS AGO, A SIMILAR EVENT HAD OCCURRED WITH THE SAME BATCH SPIKE, BUT IN THE PREVIOUS CASE THE SMART-SITE HAD DETACHED COMPLETELY. BOTH EVENTS OCCURRED INSIDE THE ISOLATOR AND DID NOT INVOLVE PATIENTS. IN BOTH CASES, SPILLAGE OF CHEMOTHERAPEUTIC DRUG AND BREAKDOWN OF STERILITY OF THE PREPARATION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2398635 BD SMARTSITE¿ VENTED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown