BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ NEXIVA CATHETER

    MDR report key: 17119328 · Received June 13, 2023

    Report

    Report Number
    2243072-2023-01012
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 22, 2023
    Report Date
    July 28, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. D.4 DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 3032874, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO BUT THE DEFECTIVE UNIT WAS NOT VISIBLE. THEREFORE, BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECT COULD BE IDENTIFIED IN THE PROVIDED PHOTO A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. FOR A MORE THOROUGH INVESTIGATION, EITHER A PHYSICAL SAMPLE OR A PHOTO OF THE ALLEGED DEFECT WOULD NEED TO BE PROVIDED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ NEXIVA CATHETER BACKED OUT OF VEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR RNS WAS INSERTING THE PATIENT'S IV IN THE VEIN, GOT GOOD BLOOD RETURN. EE FELT RESISTANCE THREADING THE CATHETER. EE HELD STABILIZER HUB AND PULLED OUT THE NEEDLE BUT THE CATHETER AND THE NEEDLE BOTH CAME OUT AND THE NEEDLE PENETRATED EE'S GLOVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ NEXIVA CATHETER BACKED OUT OF VEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR RNS WAS INSERTING THE PATIENT'S IV IN THE VEIN, GOT GOOD BLOOD RETURN. EE FELT RESISTANCE THREADING THE CATHETER. EE HELD STABILIZER HUB AND PULLED OUT THE NEEDLE BUT THE CATHETER AND THE NEEDLE BOTH CAME OUT AND THE NEEDLE PENETRATED EE'S GLOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251810 UNSPECIFIED BD¿ NEXIVA CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown