BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 10830813 · Received November 12, 2020

    Report

    Report Number
    8041187-2020-00734
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    September 30, 2020
    Report Date
    January 19, 2021
    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

    H6 INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9143745. 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. UNFORTUNATELY, 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. PLANT WILL MONITOR THIS DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEMS EXPERIENCED LEAKAGE AT CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:SEVERAL CASES OF FLUID LEAKAGE OCCURRED IN GYNECOLOGY. NO CRACKS WERE FOUND WHEN THE NURSE CHECKED, BUT FLUID LEAKAGE OCCURRED AT THE JUNCTION OF HEPARIN CAP AND HARD SHELL, AND CRACKS WERE SUSPECTED AT THE ADHESION.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEMS EXPERIENCED LEAKAGE AT CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEVERAL CASES OF FLUID LEAKAGE OCCURRED IN GYNECOLOGY. NO CRACKS WERE FOUND WHEN THE NURSE CHECKED, BUT FLUID LEAKAGE OCCURRED AT THE JUNCTION OF HEPARIN CAP AND HARD SHELL, AND CRACKS WERE SUSPECTED AT THE ADHESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298930 BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9143745

    Patients

    Seq Age Sex Outcome Treatment
    1