BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE VIAL ACCESS DEVICE VENTED WITH SS

    MDR report key: 12054178 · Received June 23, 2021

    Report

    Report Number
    9616066-2021-51367
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 27, 2021
    Report Date
    July 29, 2021
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 6/8/2021. H.6. INVESTIGATION: ONE MV0400-0006 SAMPLE WAS RECEIVED FOR INVESTIGATION CONNECTED TO A VIAL WHICH CONTAINED SOME RESIDUAL MEDICATION. FUNCTIONAL TESTING OF THE RETURNED VIAL ACCESS DEVICE (VAD) CONFIRMED THE CUSTOMER'S EXPERIENCE AS IT WAS NOT POSSIBLE TO INJECT FLUID THROUGH THE SMARTSITE. A VISUAL INSPECTION OF THE SAMPLE CONFIRMED THE SOURCE OF THE OCCLUSION WAS AN EXCESS OF SOLVENT AT THE JOINT OF THE SMARTSITE TO THE VAD. THE DETAILS OF THIS FEEDBACK WERE SHARED WITH THE LEGAL MANUFACTURER OF THE PRODUCT, YUKON MEDICAL LLC, FOR INVESTIGATION. IT WAS CONFIRMED THAT THE BLOCKAGE WAS CAUSED BY AN EXCESSIVE AMOUNT OF SOLVENT BEING APPLIED TO THE DEVICE DURING MANUFACTURE. THE LOT NUMBER WAS NOT AVAILABLE AND THEREFORE IT IS NOT POSSIBLE TO PERFORM A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THIS PARTICULAR PRODUCT. THE QUALITY TEAM AT THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS COMPLAINT IN ORDER TO BE AWARE OF THE REPORTED FAILURE MODE DURING FUTURE PRODUCTION OF THIS PRODUCT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SINGLE VIAL ACCESS DEVICE VENTED WITH SS EXPERIENCED FLOW ISSUES AND WAS CLOGGED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "I HAVE A DRUG VIAL THAT HAS A DISPENSING PIN ATTACHED WHICH IS APPARENTLY ¿BLOCKED¿ AND DOES NOT ALLOW FOR ANY DRUG TO BE OBTAINED VIA THE VIAL ACCESS PIN."

    Additional Manufacturer Narrative · 1

    " MEDICAL 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. "

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SINGLE VIAL ACCESS DEVICE VENTED WITH SS EXPERIENCED FLOW ISSUES AND WAS CLOGGED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "I HAVE A DRUG VIAL THAT HAS A DISPENSING PIN ATTACHED WHICH IS APPARENTLY ¿BLOCKED¿ AND DOES NOT ALLOW FOR ANY DRUG TO BE OBTAINED VIA THE VIAL ACCESS PIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945736 SINGLE VIAL ACCESS DEVICE VENTED WITH SS INTRAVASCULAR ADMINISTRATION SET FPA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1