BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM

    MDR report key: 10113168 · Received June 2, 2020

    Report

    Report Number
    1710034-2020-00353
    Event Type
    Malfunction
    Date Received
    June 2, 2020
    Date of Event
    May 13, 2020
    Report Date
    June 24, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835363
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. 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 SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM DRAGS WHEN YOU PULL BACK RATHER THAN BEING SMOOTH. THIS OCCURRED ON 5 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383536 BATCH NO: 9233236. IT WAS REPORTED THAT WHEN THE CATHETER IS PULLED BACK, IT DRAGS INSTEAD OF BEING SMOOTH.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM DRAGS WHEN YOU PULL BACK RATHER THAN BEING SMOOTH. THIS OCCURRED ON 5 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383536 BATCH NO: 9233236. IT WAS REPORTED THAT WHEN THE CATHETER IS PULLED BACK, IT DRAGS INSTEAD OF BEING SMOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571712 BD NEXIVA CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383536 9233236 30382903835363

    Patients

    Seq Age Sex Outcome Treatment
    1 Other