BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEOFLON¿ PRO IV CANNULA

    MDR report key: 16151985 · Received January 12, 2023

    Report

    Report Number
    8041187-2022-00802
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    December 23, 2022
    Report Date
    February 10, 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 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 0022214. 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, THEY DID NOT DISPLAY THE AFFECTED DEVICE. ADDITIONALLY, 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. UNFORTUNATELY 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 5 OF THE BD NEOFLON¿ PRO IV CANNULA CATHETER TIP BROKEN DURING CANNULATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER TIP BROKEN DURING CANNULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 OF THE BD NEOFLON¿ PRO IV CANNULA CATHETER TIP BROKEN DURING CANNULATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER TIP BROKEN DURING CANNULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464543 BD NEOFLON¿ PRO IV CANNULA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 0022214

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown