BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS GN 18GA X 1.16IN PRN-CAP Y

    MDR report key: 9554383 · Received January 6, 2020

    Report

    Report Number
    3006948883-2019-01176
    Event Type
    Malfunction
    Date Received
    January 6, 2020
    Date of Event
    December 11, 2019
    Report Date
    January 16, 2020
    Manufacturer
    BD (SUZHOU)
    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 8325823. OUR RECORDS SHOW THAT THIS IS THE SECOND 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 SHIELD ACTIVATION FAILURE OCCURRED DURING USE WITH A PEGASUS GN 18GA X 1.16IN PRN-CAP Y. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "REPLACED 18GA PEGASUS FOR PATIENT WHO IS READY TO TASK ENHANCED CT EXAMINATION. AFTER COMPLETED PENETRATION AND DURING NEEDLE RETRACTION,IT'S NOTICED THAT SAFETY SHIELD SEMI-ACTIVATED."

    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 SHIELD ACTIVATION FAILURE OCCURRED DURING USE WITH A PEGASUS GN 18GA X 1.16IN PRN-CAP Y. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "REPLACED 18GA PEGASUS FOR PATIENT WHO IS READY TO TASK ENHANCED CT EXAMINATION. AFTER COMPLETED PENETRATION AND DURING NEEDLE RETRACTION, IT'S NOTICED THAT SAFETY SHIELD SEMI-ACTIVATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19147 PEGASUS GN 18GA X 1.16IN PRN-CAP Y INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8325823

    Patients

    Seq Age Sex Outcome Treatment
    1 Other