BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA SINGLE PORT

    MDR report key: 20852902 · Received December 5, 2024

    Report

    Report Number
    1710034-2024-01431
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    November 22, 2024
    Report Date
    December 19, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903835126
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383512 AND LOT NUMBER 4212433, 4212436. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    PLEASE CONFIRM WHICH LOT IS FOR FIRST INCIDENT AND WHICH LOT IS FOR SECOND INCIDENT? EIGHT EXAMPLES I HAVE ARE LOT # 4212436, TWO EXAMPLES ARE LOT # 4212433.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA SINGLE PORT NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRACTICE HAS REPORTED ISSUES WITH NEXIVA 22GA, 383512 (MAYO 338509), LOTS 4212436 AND 4212433. WHEN THREADING THE CATHETER INTO THE VEIN IT IS BENDING IN THE PATIENT. THEY HAVE ANOTHER INCIDENT WITH THE NEEDLE PUNCTURING THE CATHETER DURING INSERTION. I HAVE ADDED TERRA POLLERT TO THIS EMAIL. SHE WILL BE ABLE TO PROVIDE SAMPLES AND ANSWER ANY ADDITIONAL QUESTIONS. PLEASE (B)(6) AS THE PRIMARY CONTACT FOR THIS EVENT AND KEEP ME AND (B)(6) ON ANY FUTURE CORRESPONDENCES FOR AWARENESS. I APPRECIATE THE ASSISTANCE WITH THIS. ADDITIONAL INFO 3 DEC ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. JUST CAUSING ADDITIONAL POKES FOR THE PATIENT. TOTAL NUMBER OF OCCURRENCES? I HAVE 10 PRODUCT PACKAGES ON MY DESK, BUT I KNOW THERE HAVE BEEN MORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050734 BD NEXIVA SINGLE PORT PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4212433 00382903835126

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown