BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 12351671 · Received August 20, 2021

    Report

    Report Number
    2243072-2021-02142
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Date of Event
    July 23, 2021
    Report Date
    August 11, 2021
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED . AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INVESTIGATION SUMMARY: A MV0420-0006 PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 202040. FROM THE INFORMATION PROVIDED BY THE CUSTOMER IT APPEARS THAT THE SMARTSITE SEPARATED FROM THE VIAL ACCESS DEVICE DURING USE. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. 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 REPORTED FAULT. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 202040 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. ALTHOUGH IT WAS NOT POSSIBLE TO DETERMINE A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE, AS A RESULT OF A SMALL NUMBER OF SIMILAR REPORTS YUKON MEDICAL LLC HAVE IMPLEMENTED ADDITIONAL IN-PROCESS TESTING OF THIS PRODUCT DURING FUTURE PRODUCTION. 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 · 1

    IT WAS REPORTED THAT THE SPIKE DETACHED FROM THE SMARTSITE 20MM VENTED VIAL ACCESS DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE NFC SS, OF THE SPIKE MV0420-0006 LOT 202040 EXPIRING 2023-10-15 HAS DETACHED FROM ITS PLACE. THE WELD BROKE, THE TECHNICIAN JUST HEARD A "CLICK". DRUG CARBOPLATIN TEVA 450 MG FL LOT 20J28KE EXPIRY 10.2022. SPIKE NOT FOUND."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243854 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA 202040

    Patients

    Seq Age Sex Outcome Treatment
    1