BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD CATHETER

    MDR report key: 10657021 · Received October 9, 2020

    Report

    Report Number
    2243072-2020-01612
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    September 17, 2020
    Report Date
    September 23, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). UNKNOWN MANUFACTURER: (B)(4). INVESTIGATION: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, MATERIAL NUMBER, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. DHR COULD NOT BE PERFORMED DUE TO UNKNOWN LOT#. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD CATHETER WAS DAMAGED AND RUPTURED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT EXTENSION TUBE BROKE DURING AN INJECTION. EVENT DESCRIPTION STATES: I WAS IN AN ADENA HEALTH CENTER TODAY AND THEY TOLD ME THEY HAD NEXIVA 22 GAUGE DIFFUSICS EXTENSION TUBING BREAK DURING INJECTION. THEY DID NOT HAVE THE PRODUCT OR KNOW THE LOT NUMBER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124340 UNSPECIFIED BD CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other