BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEE H10

    MDR report key: 10199708 · Received June 26, 2020

    Report

    Report Number
    8041187-2020-00364
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    June 6, 2020
    Report Date
    August 17, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9173711. 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, OUR ENGINEERS WERE ABLE TO EVALUATE THE EXPANDED TUBING IN THE DEVICE SUBMITTED BY THE FACILITY. BASED ON THEIR EVALUATION AND THE DESCRIPTION OF THE EVENT, THEY WERE ABLE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS THE FORCING OF FLUID THROUGH THE DEVICE DURING INJECTION. THE BD PEGASUS IS AN INFUSION ONLY DEVICE AND IS NOT RATED FOR HIGH PRESSURE INJECTIONS. BD ENCOURAGES THE REVIEW OF THE INSTRUCTIONS FOR USE INCLUDED WITH ALL PEGASUS UNITS; BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM (STRAIGHT LUER WITH PRN) 20GA X 1.16IN 1.1MM X 30MM 25 200 CHINA MULTI 383742 EXPERIENCED DEFECTIVE/DAMAGED TUBING WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS ONE PRODUCT EXPLODED IN THE PROCESS OF CT, WHICH LED TO THE CUSTOMER'S DOUBT ABOUT THE QUALITY OF BD PRODUCTS, AND THE DEPARTMENT REQUIRED WRITTEN QUALITY TEST REPORT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE BRAND NAME: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM (STRAIGHT LUER WITH PRN) 20GA X 1.16IN 1.1MM X 30MM 25 200 CHINA MULTI 383742. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM (STRAIGHT LUER WITH PRN) 20GA X 1.16IN 1.1MM X 30MM 25 200 CHINA MULTI 383742 EXPERIENCED DEFECTIVE/DAMAGED TUBING WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS ONE PRODUCT EXPLODED IN THE PROCESS OF CT, WHICH LED TO THE CUSTOMER'S DOUBT ABOUT THE QUALITY OF BD PRODUCTS, AND THE DEPARTMENT REQUIRED WRITTEN QUALITY TEST REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667970 SEE H10 INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9173711

    Patients

    Seq Age Sex Outcome Treatment
    1 Other