BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 18196669 · Received November 22, 2023

    Report

    Report Number
    1710034-2023-01337
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    September 14, 2023
    Report Date
    November 8, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K102520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF A DEFECTIVE DEVICE WAS CONFIRMED AND THE CAUSE WAS PACKAGING RELATED. ONE 22G NEXIVA UNIT FROM LOT #3116955 WAS PROVIDED FOR INVESTIGATION. THE NEXIVA CATHETER WAS CAUGHT BETWEEN THE SEALING SURFACES OF THE TOP AND BOTTOM WEB PACKAGING, WHICH CREATED GAPS IN THE SEAL. THE APPROPRIATE MANUFACTURING PERSONNEL WERE NOTIFIED OF THIS COMPLAINT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. REPORTER FACILITY FULL NAME: (B)(6) MEDICAL CENTER ELK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IV CAME OUT OF PACKAGING WITH MANUFACTURING DEFECTS. SEE PICTURE FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041887 BD NEXIVA PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3116955 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown