BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENRY SCHEIN 30G SHORT METAL HUB NEEDLE

    MDR report key: 545368 · Received March 31, 2004

    Report

    Report Number
    1412902-2004-00155
    Event Type
    Malfunction
    Date Received
    March 31, 2004
    Date of Event
    January 27, 2004
    Report Date
    March 17, 2004
    Manufacturer
    DENTSPLY MPL
    Product Code
    DZM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THE CAP OF THE NEEDLE FELL OFF AFTER DOCTOR HAD USED THE NEEDLE ON THE PATIENT. THE DOCTOR WAS STUCK WHEN DOCTOR PICKED UP THE NEEDLE TO ADMINISTER THE SECOND INJECTION. THERE WAS NO REPORT OF INJURY AND NO REPORT OF TETANUS OR GAMMA GLOBULIN INJECTIONS FOLLOWING THE INCIDENT. BLOOD WAS DRAWN FOR TESTING WITH REPORTED NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HENRY SCHEIN 30G SHORT METAL HUB NEEDLE DENTAL NEEDLE DZM DENTSPLY MPL NA 7249

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other