BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 15714661 · Received November 2, 2022

    Report

    Report Number
    3014704491-2022-00534
    Event Type
    Malfunction
    Date Received
    November 2, 2022
    Date of Event
    October 7, 2022
    Report Date
    November 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

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2173584. 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 PHOTOGRAPH WAS PROVIDED SHOWING THAT BLOOD HAD SEEP THROUGH THE SEPTUM OF THE DEVICE. THE ISSUE HAS BEEN CONFIRMED. MANY FACTORS CAN CONTRIBUTE TO THIS TYPE OF EVENT, AND THE AFFECTED SAMPLE IS OFTEN REQUIRED TO MAKE A DEFINITIVE IDENTIFICATION OF THE CAUSE. UNFORTUNATELY, THE AFFECTED SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS AND WERE FREE OF LEAKS. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT, OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEMS EXPERIENCED LEAKAGE AT THE ADAPTOR SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: DURING USE, BLOOD OOZES WHEN 4 NEEDLE CORES ARE USED CONTINUOUSLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEMS EXPERIENCED LEAKAGE AT THE ADAPTOR SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: DURING USE, BLOOD OOZES WHEN 4 NEEDLE CORES ARE USED CONTINUOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2913102 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 2173584

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown