BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STPCK Q-SYTE WHT 360DEG W/O NUT CAP NS

    MDR report key: 9808206 · Received March 9, 2020

    Report

    Report Number
    9610847-2020-00089
    Event Type
    Malfunction
    Date Received
    March 9, 2020
    Date of Event
    February 17, 2020
    Report Date
    March 11, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 8121637 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. ALL QUALITY INSPECTIONS PERFORMED WERE FOUND TO BE WITHIN SPECIFICATION. AS NEITHER A PHYSICAL SAMPLE NOR A PICTURE SAMPLE WAS AVAILABLE, OUR QUALITY ENGINEER TEAM WAS UNABLE TO COMPLETE A THOROUGH SAMPLE INVESTIGATION. IN RESPONSE TO THIS REPORTED INCIDENT AND RELATED REPORTS, A QUALITY ALERT HAS BEEN ISSUED TO ALL APPLICABLE PERSONNEL. AT THIS TIME, A MANUFACTURING RELATED CAUSE COULD NOT BE DETERMINED. OUR QUALITY TEAM WILL BE CLOSELY MONITORING THE PRODUCTION PROCESS FOR SIGNS OF FOREIGN MATTER AND OTHER EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STPCK Q-SYTE WHT 360DEG W/O NUT CAP NS EXPERIENCED FOREIGN MATTER IN THE FLUID PATHWAY WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A HAIR WAS IN THE PACKAGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 STPCK Q-SYTE WHT 360DEG W/O NUT CAP NS EXPERIENCED FOREIGN MATTER IN THE FLUID PATHWAY WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A HAIR WAS IN THE PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267899 STPCK Q-SYTE WHT 360DEG W/O NUT CAP NS STOP COCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8121637

    Patients

    Seq Age Sex Outcome Treatment
    1 Other