BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEOFLON¿ PRO IV CATHETER

    MDR report key: 16075179 · Received December 29, 2022

    Report

    Report Number
    8041187-2022-00777
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    December 9, 2022
    Report Date
    February 7, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 1 PHOTO AND 1 VIDEO SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LEAKAGE AT INSERTION SITE WAS NOT CONFIRMED UPON INSPECTION OF THE PHOTO AND VIDEO. THE CATHETER DEFECT COULD NOT BE SEEN CLEARLY FROM THE VIDEO RETURNED. BD CANNOT CONFIRM THE CAUSE OF THE FAILURE TO OUR MANUFACTURING PROCESS SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. DHR REVIEWED WAS PERFORMED ON BATCH# 2111490.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEOFLON PRO IV CATHETER LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT HAPPENED IN WARDS, LEAKAGE FROM CATHETER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEOFLON¿ PRO IV CATHETER LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT HAPPENED IN WARDS, LEAKAGE FROM CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354435 BD NEOFLON¿ PRO IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 2111490

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown