BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENIPUNCTURE NEEDLE-PRO DEVICE

    MDR report key: 1397864 · Received April 8, 2009

    Report

    Report Number
    1217052-2009-00017
    Event Type
    Malfunction
    Date Received
    April 8, 2009
    Date of Event
    March 9, 2009
    Report Date
    March 13, 2009
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JKA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS EVALUATION: THE USER FACILITY DID NOT RETAIN THE EVENT SAMPLE. THEY DID RETURN SIX UNUSED SAMPLES, FROM THE SAME LOT NUMBER, FOR INVESTIGATION. THOSE SIX SAMPLES WERE VISUALLY AND FUNCTIONALLY TESTED AND NO MALFUNCTION WAS FOUND. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO PROBLEMS DURING MANUFACTURE THAT WOULD RELATE TO THIS EVENT. A REVIEW OF THE COMPLAINTS DATABASE WAS PERFORMED AND NO OTHER REPORTS HAVE BEEN RECEIVED ON THIS DEVICE LOT NUMBER. REVIEW OF THE INSTRUCTIONS FOR USE REVEALS THE FOLLOWING INSTRUCTIONS: "ENSURE THE NEEDLE IS FULLY ENGAGED IN THE PROTECTIVE SHEATH BEFORE DISPOSAL." "AFTER USE, PLACE SHARPS IN SUITABLE SHARPS CONTAINER. DISPOSE OF CONTAMINATED PRODUCT IN A SAFE MANNER ACCORDING TO THE CENTERS FOR DISEASE CONTROL AND PREVENTION, USA AND FEDERAL/STATE/LOCAL REGULATIONS (EPA, OSHA AND HEALTH CARE FACILITY GUIDELINES OR LOCAL EQUIVALENT)."

    Description of Event or Problem · 1

    USER REPORTED ONE EVENT THE PHLEBOTOMIST HAD ENGAGED THE NEEDLE INTO THE NEEDLE PROTECTION DEVICE, HEARD THE "CLICK" AND THEN WHEN PICKING UP MATERIALS FROM ER BEDSIDE SUSTAINED A NEEDLE STICK TO PALM. TREATMENT WILL BE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENIPUNCTURE NEEDLE-PRO DEVICE 75 JKA - ADAPTOR, BLOOD COLLECTING TUBE, SINGLE-USE JKA SMITHS MEDICAL ASD, INC. 1529396

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention