BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ BL 22GA X 1.00IN QSYTE-CAP Y

    MDR report key: 12186071 · Received July 17, 2021

    Report

    Report Number
    8041187-2021-00606
    Event Type
    Malfunction
    Date Received
    July 17, 2021
    Date of Event
    June 18, 2021
    Report Date
    September 10, 2021
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: 7/5/2021. H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1053342. 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. ADDITIONALLY THE SAMPLE SUBMITTED TO OUR FACILITY WAS REVIEWED BY OUR TEAM OF QUALITY ENGINEERS. BASED ON MICROSCOPIC EVALUATION OF THE SEPTUM THEY WERE ABLE TO IDENTIFY TWO SMALL TEARS IN THE SEPTUM THAT MAY HAVE LEAD TO LEAKAGE OF THE DEVICE. FUNCTIONAL TESTING OF THE UNIT WAS NOT ABLE TO REPLICATE THIS REPORTED LEAKAGE, BUT THE ISSUE HAS BEEN CONFIRMED. UNFORTUNATELY THE ROOT CAUSE FOR THESE TEARS COULD NOT BE DETERMINED, AS THE PROVIDED DEVICE, DISPLAYED NO OBVIOUS INDICATIVE MARKINGS THAT WOULD ASSOCIATE THEM WITH EITHER DAMAGE FROM USE OR DAMAGE SUSTAINED DURING MANUFACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PEGASUS¿ BL 22GA X 1.00IN QSYTE-CAP Y THERE WAS LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE Q-SYTE CONNECTOR ON THE INDWELLING NEEDLE IN NEUROSURGERY WAS FOUND TO BE LEAKING."

    Additional Manufacturer Narrative · 1

    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 WHEN USING THE BD PEGASUS¿ BL 22GA X 1.00IN QSYTE-CAP Y THERE WAS LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE Q-SYTE CONNECTOR ON THE INDWELLING NEEDLE IN NEUROSURGERY WAS FOUND TO BE LEAKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083336 BD PEGASUS¿ BL 22GA X 1.00IN QSYTE-CAP Y INTRAVASCULAR CATHETER FOZ 1053342

    Patients

    Seq Age Sex Outcome Treatment
    1