BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS YEL 24GA X 0.75IN PRN-CAP Y

    MDR report key: 9733531 · Received February 20, 2020

    Report

    Report Number
    3006948883-2020-00056
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    January 7, 2020
    Report Date
    February 5, 2020
    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 · 1

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141620. 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. INVESTIGATION CONCLUSION: NO SAME DEFECT COMPLAINT FROM SAME LOT, NO TREND FOR THIS PRODUCT. ROOT CAUSE DESCRIPTION: A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEGASUS YEL 24GA X 0.75IN PRN-CAP Y COULD NOT CONNECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE USAGE OF THE INDWELLING NEEDLE, THE INDWELLING NEEDLE INTERFACE AND CLAVE CONNECTOR CANNOT BE TIGHTENED. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199806 PEGASUS YEL 24GA X 0.75IN PRN-CAP Y CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9141620

    Patients

    Seq Age Sex Outcome Treatment
    1 Other