BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALHOLD STD BORE EXTSET W/VLCATHETER SECUREMENT

    MDR report key: 1753556 · Received July 12, 2010

    Report

    Report Number
    6000001-2010-01184
    Event Type
    Malfunction
    Date Received
    July 12, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 13, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. THE CORRECT FDA PRODUCT CODE IS OJA (ENFORCEMENT DISCRETION). THIS CODE IS EXEMPT FROM A 510K NUMBER. (B)(4)

    Description of Event or Problem · 1

    THE BAXTER SALES REPRESENTATIVE CALL ON THE CUSTOMER'S BEHALF TO REPORT THE THREADS BROKE OFF THE FEMALE LUER WHILE REMOVING A CONNECTION. THIS INCIDENT OCCURRED WITH THE VITALHOLD STANDARD BORE EXTENSION SET, PRODUCT CODE 6N8220, WITH AN UNKNOWN LOT NUMBER. THIS INCIDENT OCCURRED DURING USE. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALHOLD STD BORE EXTSET W/VLCATHETER SECUREMENT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1