BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9152094 · Received October 3, 2019

    Report

    Report Number
    9610847-2019-00599
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    September 17, 2019
    Report Date
    November 19, 2019
    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

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8213745. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. THE RETURNED DEVICE WAS SUBJECTED TO OCCLUSION TESTING AND FOUND TO BE FREE OF ANY OBSERVABLE OR TESTABLE OBSTRUCTION. BASED ON OUR TESTING RESULTS, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE STPCK Q-SYTE RED 360DEG W/O NUT CAP NS HAS BEEN FOUND EXPERIENCING FLOW ISSUES DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WHEN PRIMING WITH HEPARIN AND SALINE, HCP COMPLAINED THE MAIN PORT PART WASN'T LOCKED.(IT DIDN'T FLOW).

    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.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE STPCK Q-SYTE RED 360DEG W/O NUT CAP NS HAS BEEN FOUND EXPERIENCING FLOW ISSUES DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: WHEN PRIMING WITH HEPARIN AND SALINE, HCP COMPLAINED THE MAIN PORT PART WASN'T LOCKED.(IT DIDN'T FLOW).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948307 STPCK Q-SYTE RED 360DEG W/O NUT CAP NS STOPCOCK FMG BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8213745

    Patients

    Seq Age Sex Outcome Treatment
    1 Other