BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS GN 18GA X 1.16IN PRN-CAP Y

    MDR report key: 9078008 · Received September 17, 2019

    Report

    Report Number
    3006948883-2019-00766
    Event Type
    Malfunction
    Date Received
    September 17, 2019
    Date of Event
    September 2, 2019
    Report Date
    October 11, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233213. 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. SAMPLES WERE SUBMITTED FOR EVALUATION; BD ENGINEERS WERE ABLE TO OBSERVE A DAMAGE TO THE V-CLIP DURING THE VISUAL OBSERVATION OF THE DEVICE. THE ROOT CAUSE FOR THIS OCCURRENCE MOST LIKELY DUE TO A MISSING PIN IN THE MANUFACTURING MACHINERY THAT LEAD TO A MISALIGNMENT DURING ASSEMBLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEGASUS GN 18GA X 1.16IN PRN-CAP Y EXPERIENCED A CATHETER THAT BROKE/SEPARATED FROM HUB, AND LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S FOUND THAT NEEDLE PADDLE HUB FELL OFF DURING PENETRATION PROCESS, RESULT IN BLOOD LEAKAGE ON PATIENT; LEAKED BLOOD IS ABOUT 5ML. NO MEDICAL INTERVENTION INVOLVED IN THIS CASE, NO ADVERSE EVENT OCCURED ON PATIENT AND NO BLOOD OR BODILY FLUIDS EXPOSED TO THE END USER.

    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 THAT THE PEGASUS GN 18GA X 1.16IN PRN-CAP Y EXPERIENCED A CATHETER THAT BROKE/SEPARATED FROM HUB, AND LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S FOUND THAT NEEDLE PADDLE HUB FELL OFF DURING PENETRATION PROCESS, RESULT IN BLOOD LEAKAGE ON PATIENT. LEAKED BLOOD IS ABOUT 5ML. NO MEDICAL INTERVENTION INVOLVED IN THIS CASE. NO ADVERSE EVENT OCCURED ON PATIENT. NO BLOOD OR BODILY FLUIDS EXPOSED TO THE END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872598 PEGASUS GN 18GA X 1.16IN PRN-CAP Y INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 8233213

    Patients

    Seq Age Sex Outcome Treatment
    1 Other