BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA DIFFUSICS 24G X 0.75 IN

    MDR report key: 8392371 · Received March 5, 2019

    Report

    Report Number
    9610847-2019-00198
    Event Type
    Malfunction
    Date Received
    March 5, 2019
    Date of Event
    December 13, 2018
    Report Date
    February 20, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903835905
    PMA / PMN Number
    K173354
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: SINCE A LOT NUMBER COULD NOT BE CONNECTED TO THE DEVICE IDENTIFIED IN THE COMPLAINT, BD INVESTIGATORS COULD NOT CONDUCT A DEVICE HISTORY REVIEW FOR THIS EVENT. ADDITIONALLY, A SAMPLE HAS NOT YET BEEN SUBMITTED FOR EVALUATION AND TESTING, PREVENTING BD ENGINEERS FROM CONDUCTING A FULL INVESTIGATION AND DETERMINING A ROOT CAUSE OF THE FAILURE MODE IDENTIFIED IN YOUR DESCRIPTION OF THE EVENT. INVESTIGATION CONCLUSION: NO SAMPLE, NO LOT. ROOT CAUSE DESCRIPTION: NO SAMPLE, NO LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEXIVA DIFFUSICS 24G X 0.75 IN HAD A CRACK ON THE TUBING AND LEAKED WHEN FLUSHED. THE FOLLOWING WAS REPORTED, "PIV CATHETER CRACKED ON TUBING, LEAKING WHEN FLUSHING HAD TO BE REMOVED. NEXIVIA DIFFUSICS: REF (B)(4), 24GA 0,75IN GRM 92575 UNAWARE OF LOT#."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186254 NEXIVA DIFFUSICS 24G X 0.75 IN INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN 30382903835905

    Patients

    Seq Age Sex Outcome Treatment
    1 Other