BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER

    MDR report key: 15997230 · Received December 16, 2022

    Report

    Report Number
    9610847-2022-00475
    Event Type
    Malfunction
    Date Received
    December 16, 2022
    Date of Event
    November 28, 2022
    Report Date
    January 25, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903835943
    PMA / PMN Number
    K123734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: SINCE NO PHOTOS OR SAMPLES DISPLAYING THE REPORTED CONDITION OF CATHETER TIP INTEGRITY WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. DHR FOR THIS LOT WAS REVIEWED AND THERE ARE NO INTERNAL REJECTS RELATED TO THE REPORTED ISSUE BY THE CUSTOMER. ACCORDING TO THE QUALITY RECORDS ALL THE INSPECTIONS OF THE SAMPLING PLAN MET THE ACCEPTANCE CRITERIA.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT 3 BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER NEEDLE RUSTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OMITTED STATED THAT THE NURSES OPENED THREE PACKAGES IN A ROW THAT ALL HAD THE SAME PROBLEM OF YELLOWISH RUSTED TIPS. THE LOT NUMBER IS 0203331. OMITTED ORDERS THIS PRODUCT FROM OMITTED AND THE ITEM HAS BEEN ON BACK ORDER AND THE PRODUCT THAT WAS RECEIVED HAS THIS YELLOWISH RUSTED TIPS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER NEEDLE RUSTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OMITTED STATED THAT THE NURSES OPENED THREE PACKAGES IN A ROW THAT ALL HAD THE SAME PROBLEM OF YELLOWISH RUSTED TIPS. THE LOT NUMBER IS 0203331. OMITTED ORDERS THIS PRODUCT FROM OMITTED AND THE ITEM HAS BEEN ON BACK ORDER AND THE PRODUCT THAT WAS RECEIVED HAS THIS YELLOWISH RUSTED TIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1868244 BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 383594 0203331 30382903835943

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown