BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHARPX NEEDLE DESTRUCTION UNIT

    MDR report key: 280574 · Received May 22, 2000

    Report

    Report Number
    1065528-2000-00001
    Event Type
    Other
    Date Received
    May 22, 2000
    Date of Event
    April 21, 2000
    Report Date
    May 19, 2000
    Manufacturer
    BIOMEDICAL DISPOSAL, INC.
    Product Code
    MTV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    4/21/2000 DURING MORNING CLINIC SET-UP, NURSE REMOVED DEVICE FROM OVERNIGHT CHARGER TO PLACE IN PT CARE AREA. WHEN PLACING UNIT INTO STATIONARY BASE, NURSE PLACED FINGER OVER INSERTION POINT FOR NEEDLE. REPORTEDLY, A "BURNED OR BLACK" METAL FRAGMENT (RESIDUAL FROM BURNED NEEDLE) BECAME LODGED IN NURSE'S FINGER. FRAGMENT WAS REMOVED BY CLINIC MANAGER & DISCARDED. CLINIC MANAGER REPORTED INCIDENT TO CORPORATE OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPX NEEDLE DESTRUCTION UNIT NEEDLE DESTRUCTION UNIT MTV BIOMEDICAL DISPOSAL, INC. NDU-1 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other