BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALHOLD STD BORE EXTSET W/VLCATHETER SECUREMENT

    MDR report key: 1940036 · Received December 29, 2010

    Report

    Report Number
    6000001-2010-06284
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 15, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION OF NO FLOW WAS NOT CONFIRMED; THEREFORE THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE BATCH REVIEW CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS 510K EXEMPT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED EXPERIENCING A NO FLOW AT THE LUER. THE REPORTED CONDITION OCCURRED DURING PRIMING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1