BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS YEL 24GA X 0.75IN PRN-CAP Y

    MDR report key: 8600549 · Received May 10, 2019

    Report

    Report Number
    3006948883-2019-00363
    Event Type
    Malfunction
    Date Received
    May 10, 2019
    Date of Event
    April 18, 2019
    Report Date
    June 7, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233187. 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. THE CUSTOMER PROVIDED A PHOTO OF THE REPORTED FAILURE MODE. BASED OFF THE PHOTO THIS DEFECT MAY HAVE BEEN CAUSED BY THE PINCH CLAMP USED. AS NO SAMPLE WAS RETURNED, THE CLAMP COULD NOT BE TESTED. THE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEGASUS YEL 24GA X 0.75IN PRN-CAP Y EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE REPORTED THAT THE EXTENSION TUBING WAS BROKEN FROM THE CLAMP POSITION.

    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 YEL 24GA X 0.75IN PRN-CAP Y EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSE REPORTED THAT THE EXTENSION TUBING WAS BROKEN FROM THE CLAMP POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391476 PEGASUS YEL 24GA X 0.75IN PRN-CAP Y IV CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 8233187

    Patients

    Seq Age Sex Outcome Treatment
    1 Other