BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PIV

    MDR report key: 22745584 · Received August 7, 2025

    Report

    Report Number
    2243072-2025-00959
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 22, 2025
    Report Date
    August 21, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. IN THIS MDR, BD FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AS THE MANUFACTURING SITE IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD: THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER COMPLAINTS HAVE IDENTIFIED THAT CERTAIN AFFECTED LOTS MAY PREMATURELY DISENGAGE FROM THE NEEDLE DURING USE, DUE TO A MANUFACTURING DEFECT.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243436 BD PIV PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown