BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 13056145 · Received December 21, 2021

    Report

    Report Number
    8041187-2021-01066
    Event Type
    Malfunction
    Date Received
    December 21, 2021
    Date of Event
    November 24, 2021
    Report Date
    February 1, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    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

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1203475. 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. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THE AFFECTED SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. BASED ON THEIR ANALYSIS OF THE PROVIDED VIDEO OUR ENGINEERS BELIEVE THAT THE ISSUE MAY BE RELATED TO DAMAGE SUSTAINED DURING MANUFACTURE BUT ARE UNABLE TO DETERMINE A ROOT CAUSE WITH THE ABILITY TO REVIEW THE AFFECTED DEVICE.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM, THE Q-SYTE NEEDLE-FREE CONNECTOR LEAKED. THIS EVENT OCCURRED 2 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "NURSE MANAGER FOUND Q-SYTE LEAKAGE WHILE USING THE PRODUCT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM, THE Q-SYTE NEEDLE-FREE CONNECTOR LEAKED. THIS EVENT OCCURRED 2 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "NURSE MANAGER FOUND Q-SYTE LEAKAGE WHILE USING THE PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950019 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 1203475

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown