BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 12072226 · Received June 25, 2021

    Report

    Report Number
    2243072-2021-01758
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Date of Event
    May 27, 2021
    Report Date
    July 22, 2021
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 2021-07-06. INVESTIGATION SUMMARY: ONE MV0420-0006 SAMPLE WAS RECEIVED IN OPENED PACKAGING, FROM LOT: 202040. THE SAMPLE WAS RECEIVED CONNECTED TO A DARZALEX 1.8MG VIAL. A VISUAL INSPECTION OF THE PRODUCT CONFIRMED THE CUSTOMER'S EXPERIENCE, AS THE SMARTSITE COMPONENT WAS RECEIVED SEPARATED FROM THE VIAL ACCESS DEVICE. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. A DEFINITIVE ROOT CAUSE FOR OBSERVED SEPARATION COULD NOT BE DETERMINED, HOWEVER IT IS POSSIBLE THAT IT OCCURRED AS A RESULT OF AN INCONSISTENT OR INSUFFICIENT APPLICATION OF GLUE, COUPLED WITH THE TWISTING FORCE DURING ENGAGEMENT OR DISENGAGEMENT OF THE SMARTSITE. 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. IN ORDER TO ENSURE THAT REPORTS OF THIS NATURE ARE MINIMISED IN FUTURE, 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 · 0

    IT WAS REPORTED THAT THE SMARTSITE 20MM VENTED VIAL ACCESS DEVICE TIP REMAINED ON THE SYRINGE AFTER UNSCREWING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "WHEN UNSCREWING THE SYRINGE, THE TIP OF THE BD VENTED ACCESS DEVICE (TEXIUM VIAL ADAPTOR) REMAINED ON THE SYRINGE. THIS CAN BE TAKEN OFF, SO IT DOES NOT APPEAR TO BE GLUED ON OR SIMILAR."

    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 IN AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SMARTSITE 20MM VENTED VIAL ACCESS DEVICE TIP REMAINED ON THE SYRINGE AFTER UNSCREWING IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WHEN UNSCREWING THE SYRINGE, THE TIP OF THE BD VENTED ACCESS DEVICE (TEXIUM VIAL ADAPTOR) REMAINED ON THE SYRINGE. THIS CAN BE TAKEN OFF, SO IT DOES NOT APPEAR TO BE GLUED ON OR SIMILAR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961760 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA 202040

    Patients

    Seq Age Sex Outcome Treatment
    1