BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 18 GA 1.25 IN

    MDR report key: 13441907 · Received February 3, 2022

    Report

    Report Number
    9610847-2022-00041
    Event Type
    Malfunction
    Date Received
    February 3, 2022
    Date of Event
    January 19, 2022
    Report Date
    February 23, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903835943
    PMA / PMN Number
    K173354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE 339 REPRESENTATIVE SAMPLES AND 4 OPENED SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF CATHETER DAMAGE WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. A RANDOM SAMPLING OF THE RETURNED SAMPLES WERE TESTED FOR CATHETER PENETRATION FORCE TO SEE IF THERE WAS ANY CATHETER DAMAGE. DURING TESTING ALL SAMPLES WERE FOUND TO BE WITHIN SPECIFICATION AND HAD NO DEFECTS. BD CANNOT DETERMINE A MANUFACTURING ROOT CAUSE SINCE THE DEFECT WAS NOT CONFIRMED. THE REPORTED ISSUE OF YELLOWING WAS CONFIRMED UPON INSPECTION OF THE SAMPLES. THE INSPECTION OF THE SAMPLES FOUND ACCEPTABLE AMOUNTS OF CATHETER YELLOWING ON SOME OF THE SAMPLES. A LASER IS USED DURING THE PRODUCTION OF THESE PRODUCTS AND MINOR AMOUNTS OF YELLOWING CAN OCCUR DUE TO THE HEAT EMITTED FROM THE LASER. ALL SAMPLES EXAMINED WERE FOUND TO BE WITHIN MANUFACTURING SPECIFICATIONS FOR THE YELLOW DISCOLORATION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 18 GA 1.25 IN CATHETER WAS FOUND TO BE DEFORMED AND BULGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: BATCH NO: 1082458   IT WAS REPORTED BY THE CONSUMER THE IVS ARE BILGING AT THE TIP OF THE CATHETER, YELLOW AND MALFORMED.   VERBATIM: LOT 1082458 OF 18 GAUGE DIFFUSICS IVS ARE BULGED OUT WHERE THE SIDE PORTS ARE LOCATED AT THE TIP OF THE CATHETER. THIS AREA IS ALSO YELLOW AND MALFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 18 GA 1.25 IN CATHETER WAS FOUND TO BE DEFORMED AND BULGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BATCH NO: 1082458. IT WAS REPORTED BY THE CONSUMER THE IVS ARE BILGING AT THE TIP OF THE CATHETER, YELLOW AND MALFORMED.   VERBATIM: LOT 1082458 OF 18 GAUGE DIFFUSICS IVS ARE BULGED OUT WHERE THE SIDE PORTS ARE LOCATED AT THE TIP OF THE CATHETER. THIS AREA IS ALSO YELLOW AND MALFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174257 BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 18 GA 1.25 IN INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 383594 1082458 30382903835943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown