BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA 22 GA X 1.00IN SP WITH MAXZERO

    MDR report key: 18026959 · Received October 29, 2023

    Report

    Report Number
    1710034-2023-01236
    Event Type
    Malfunction
    Date Received
    October 29, 2023
    Date of Event
    October 12, 2023
    Report Date
    January 19, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835523
    PMA / PMN Number
    K170336
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE REPORTED DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. THE DHR FOR LOT 3234051 HAS BEEN REVIEWED. THE DHR FOR LOT 3234051 WAS BUILT AND PACKAGED ON NFA 3 FROM 03SEP2023 THROUGH 06SEP2023 FOR A QUANTITY OF (B)(4) NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA 22 GA X 1.00IN SP WITH MAXZERO SAFETY SHIELDING DID NOT ENGAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: DURING IN SERVICING OF PRODUCT, PULLED NEEDLE TO SAFETY IT AND SAFETY DID NOT ENGAGE. (B)(6) 2023. IS IT ¿PULLED NEEDLE TO SAFETY IT AND SAFETY DID NOT ENGAGE¿ IS NEEDLE SHIELDING FAILURE? OR SAFETY MECHANISM NOT DISENGAGE FROM CATHETER OR STUCK AT THE HUB? OR DIFFICULT TO REMOVE THE NEEDLE? : SAFETY SHIELDING FAILURE. HOW MANY OCCURRENCES OF DEFECTIVE SET(S) AFFECTED? : 2 INDIVIDUAL IV CATHETERS. WAS THERE ANY PATIENT¿S INVOLVEMENT? : NO, THIS WAS DURING INSERVICING. WHAT WAS THE PATIENT OUTCOME? : N/A. WAS THERE ANY DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THIS EVENT?: N/A. WHAT PROCEDURE WAS BEING PERFORMED? : INSERVICING NEW PRODUCT. WHAT MEDICATION WAS USED IN THE PROCEDURE? : N/A. SINCE SAMPLE IS NOT AVAILABLE, ARE YOU ABLE TO PROVIDE THE PHOTO/VIDEO OF THE ISSUE/DEFECTS? : N/A.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138398 BD NEXIVA 22 GA X 1.00IN SP WITH MAXZERO PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3234051 30382903835523

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown