BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 20GA 1.25IN HF Y

    MDR report key: 12565181 · Received October 1, 2021

    Report

    Report Number
    1710034-2021-00856
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    September 3, 2021
    Report Date
    October 19, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835379
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : OUR QUALITY ENGINEER INSPECTED THE SAMPLE. BD RECEIVED ONE UNIT. VISUAL INSPECTION OF THE DEVICE SHOWED THAT THERE WAS NO VISIBLE DAMAGE TO THE V-CLIP OR TIP SHIELD. FUNCTIONAL TESTING WAS PERFORMED BY ATTEMPTING TO COMPLETELY PULL BACK THE NEEDLE. IT WAS OBSERVED THAT THE NEEDLE COULD NOT BE PULLED BACK PAST A CERTAIN POINT. THE REPORTED DEFECT WAS CONFIRMED. A MICROSCOPIC INSPECTION OF THE CANNULA WAS PERFORMED AND DAMAGE TO THE CANNULA WAS OBSERVED. THE CANNULA APPEARED TO HAVE A LITTLE GROOVE CUT INTO IN AND A BUILDUP ON THE SIDES OF THE GROVE. NO BENDING OF THE NEEDLE WAS OBSERVED. DAMAGE CAUSED DURING THE MANUFACTURING PROCESSES WOULD MOST LIKELY RESULT IN A BEND OF THE CANNULA AND ARE VERY UNLIKELY TO CAUSE THE OBSERVED ROTATING GROVE/SCRATCHING IN THE CANNULA WALL; THEREFORE, THE DEFECT IS MOST LIKELY LINKED TO RAW MATERIALS. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEXIVA 20GA 1.25IN HF Y NEEDLE WOULD NOT REMOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER PUNCTURING VENFLON (PINK), IV NEEDLE NOT REMOVING. SO WHOLE INFUSION REMOVED AGAIN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEXIVA 20GA 1.25IN HF Y NEEDLE WOULD NOT REMOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER PUNCTURING VENFLON (PINK), IV NEEDLE NOT REMOVING. SO WHOLE INFUSION REMOVED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1461406 NEXIVA 20GA 1.25IN HF Y INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN 00382903835379

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown