BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMARTSITE 20MM VENTED VIAL ACCESS DEVICE

    MDR report key: 11980330 · Received June 10, 2021

    Report

    Report Number
    9616066-2021-51305
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 17, 2021
    Report Date
    July 20, 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: 2021-06-15. H6: INVESTIGATION SUMMARY ONE MV0420-0006 SAMPLE WAS RECEIVED FOR INVESTIGATION WITHOUT PACKAGING; THERE WAS NO RESIDUAL FLUID IN THE DEVICE. 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 202035 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 SET IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SPIKE BROKE OFF OF THE SMARTSITE 20MM VENTED VIAL ACCESS DEVICE DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "WHEN PULLING UP MABTHERA, THE HEADING THEN THE TEXIUM VENTED VIAL SPIKE BROKE OFF. THE VIAL SUDDENLY FELL ON THE WORK SURFACE. THE AMOUNT NEEDED FOR THE PATIENT WAS ALREADY PULLED UP, SO NO PROBLEM THERE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE REPORTED LOT # [202035] WAS NOT FOUND FOR THE REPORTED CATALOG # [MV0420-0006]. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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 · 1

    IT WAS REPORTED THAT THE SPIKE BROKE OFF OF THE SMARTSITE 20MM VENTED VIAL ACCESS DEVICE DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: "WHEN PULLING UP MABTHERA, THE HEADING THEN THE TEXIUM VENTED VIAL SPIKE BROKE OFF. THE VIAL SUDDENLY FELL ON THE WORK SURFACE. THE AMOUNT NEEDED FOR THE PATIENT WAS ALREADY PULLED UP, SO NO PROBLEM THERE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876503 SMARTSITE 20MM VENTED VIAL ACCESS DEVICE INTRAVASCULAR ADMINISTRATION SET FPA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1