BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS YEL 24GA X 0.75IN QSYTE NON-PVC

    MDR report key: 13667068 · Received March 4, 2022

    Report

    Report Number
    3014704491-2022-00089
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 21, 2022
    Report Date
    April 16, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 23-MAR-2022. H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1110742. 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. ADDITIONALLY A SAMPLE WAS SUBMITTED TO OUR FACILITY TO AID IN OUR INVESTIGATION. OUR ENGINEERS WERE ABLE TO IDENTIFY A LARGE TRANSLUCENT WHITE FOREIGN BODY LODGED IN THE EXTENSION TUBING. THE ISSUE HAS BEEN CONFIRMED. THE FOREIGN BODY WAS SUBMITTED TO A LABORATORY FOR COMPOSITION TESTING FOR IDENTIFICATION. TEST RESULTS WERE ABLE TO POSITIVELY IDENTIFY THE MATERIAL AS THERMOPLASTIC URETHANE, THIS IS THE RAW MATERIAL USED FOR THE EXTENSION TUBING COMPONENT. AFTER A REVIEW THE PRODUCTION PROCESS OUR ENGINEERS WERE ABLE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS RELATED TO THE EXTRUSION PROCESS. DURING EXTRUSION, IT IS POSSIBLE FOR THE RAW MATERIAL TO ACCUMULATE ON THE EQUIPMENT, AND BE DEPOSITED INTO THE TUBING. THIS IS CAUSED BY A COMBINATION OF EXTRUSION SPEED AND THE RATE OF MOLD-CORE INSPECTION FOR ACCUMULATED MATERIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED BD PEGASUS YEL 24GA X 0.75IN QSYTE NON-PVC HAD FOREIGN MATERIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN GYNECOLOGY, FOREIGN BODY WAS FOUND IN THE EXTENSION TUBE WHEN THE PACKAGE WAS OPENED".

    Description of Event or Problem · 0

    IT WAS REPORTED BD PEGASUS YEL 24GA X 0.75IN QSYTE NON-PVC HAD FOREIGN MATERIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN GYNECOLOGY, FOREIGN BODY WAS FOUND IN THE EXTENSION TUBE WHEN THE PACKAGE WAS OPENED"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2569795 BD PEGASUS YEL 24GA X 0.75IN QSYTE NON-PVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1110742

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown