BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS GN 18GA X 1.16IN PRN

    MDR report key: 9251638 · Received October 29, 2019

    Report

    Report Number
    3006948883-2019-00881
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Date of Event
    October 11, 2019
    Report Date
    November 21, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8170002 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, OUR QUALITY ENGINEERS WERE ABLE TO SUCCESSFULLY ACTIVATE THE SAFETY DEVICE FOR RETURNED SAMPLE, AND FOUND THE DEVICE TO FUNCTION AS INTENDED. UNFORTUNATELY WITHOUT THE ABILITY TO OBSERVE THE REPORTED FAILURE MODE, 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 PEGASUS GN 18GA X 1.16IN PRN HAS BEEN FOUND EXPERIENCING SAFETY MECHANISM FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT SAFETY SHIELD ACTIVATION FAILURE AFTER NEEDLE RETRACTION.

    Additional Manufacturer Narrative · 1

    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 PEGASUS GN 18GA X 1.16IN PRN HAS BEEN FOUND EXPERIENCING SAFETY MECHANISM FAILURE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT SAFETY SHIELD ACTIVATION FAILURE AFTER NEEDLE RETRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048329 PEGASUS GN 18GA X 1.16IN PRN CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 8170002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other