BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM

    MDR report key: 11713637 · Received April 23, 2021

    Report

    Report Number
    1710034-2021-00334
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 28, 2021
    Report Date
    June 3, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED DIFFICULT SAFETY MECHANISM/NEEDLE DISENGAGEMENT (REMOVAL). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #383511 - BATCH #0336519 THE NURSES WERE PLACING AN IV IN A TODDLER, MAYBE UNDER 2 YEARS OLD. CANNULATION WENT SMOOTHLY BUT THEY WERE NOT ABLE TO REMOVE THE NEEDLE FROM THE UNIT. COLLECTIVELY THEY USED A CLAMP ABOVE THE STABILIZATION PLATFORM AND WERE ABLE TO TWIST AND PULL THE NEEDLE OUT. THE LINE REMAINED PATENT AND THERE WAS NO NEGATIVE PATIENT OUTCOME. BOTH NURSES STATED THAT THEY DID NOT EVEN THINK THAT THE PATIENT'S PARENTS WHO WERE AT THE BEDSIDE, EVEN NOTICED THAT THEY WERE STRUGGLING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM EXPERIENCED DIFFICULT SAFETY MECHANISM/NEEDLE DISENGAGEMENT (REMOVAL). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #383511 - BATCH #0336519. THE NURSES WERE PLACING AN IV IN A TODDLER, MAYBE UNDER 2 YEARS OLD. CANNULATION WENT SMOOTHLY BUT THEY WERE NOT ABLE TO REMOVE THE NEEDLE FROM THE UNIT. COLLECTIVELY THEY USED A CLAMP ABOVE THE STABILIZATION PLATFORM AND WERE ABLE TO TWIST AND PULL THE NEEDLE OUT. THE LINE REMAINED PATENT AND THERE WAS NO NEGATIVE PATIENT OUTCOME. BOTH NURSES STATED THAT THEY DID NOT EVEN THINK THAT THE PATIENT'S PARENTS WHO WERE AT THE BEDSIDE, EVEN NOTICED THAT THEY WERE STRUGGLING .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613264 BD NEXIVA CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0336519

    Patients

    Seq Age Sex Outcome Treatment
    1