BEUDAMED
    FDA Adverse Event Injury Summary report: N

    20 G X 1.16 IN. BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER

    MDR report key: 6183315 · Received December 16, 2016

    Report

    Report Number
    8041187-2016-00093
    Event Type
    Injury
    Date Received
    December 16, 2016
    Date of Event
    November 1, 2016
    Report Date
    December 16, 2016
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 20 G X 1.16 IN. BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER BROKE OFF IN USE IN A PATIENT'S RIGHT HAND. THE PATIENT COMPLAINED OF PARALYSIS IN HER HAND AND A "CLACK" IN HER VEIN. ON (B)(6) 2016 THE PATIENT HAD SURGERY TO REMOVE THE BROKEN PIECE OF CATHETER BUT THE OPERATION FAILED TO REMOVE IT. NO IMAGING STUDIES WERE PERFORMED BEFOREHAND AS THE DOCTOR AD SURGEON WERE CERTAIN OF THE PRESENCE OF THE CATHETER IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834332 20 G X 1.16 IN. BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention