BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-LINK STD BORE IV CATH EXTWITH SILVER ANTIMICROBIAL COAT

    MDR report key: 1934965 · Received December 21, 2010

    Report

    Report Number
    6000001-2010-06074
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K081289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TWO ACTUAL SAMPLES WERE SENT IN FOR THE REPORTED NO FLOW / RESTRICTED FLOW CONDITION. A VISUAL INSPECTION OF THE SAMPLES DID NOT FIND ANY ABNORMALITIES. THE SAMPLES WERE ALSO SUBMITTED FOR FUNCTIONAL TESTING WITH THE BD SYRINGES THAT WERE SENT IN AND THE RESULTS WERE SATISFACTORY. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE REPORTED CONDITION WAS NOT CONFIRMED. THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER A V-LINK STANDARD BORE CATHETER EXTENSION SET THAT WAS OCCLUDING AT THE V-LINK LUER. ACCORDING TO THE REPORT, THE CONDITION OCCURS WHEN INFUSING DIPRIVAN/PROPOFOL AND SOMETIMES LIDOCAINE, NOT NECESSARILY TOGETHER. THE CONDITION WAS REPORTED TO HAVE OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V-LINK STD BORE IV CATH EXTWITH SILVER ANTIMICROBIAL COAT SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO UR10C09011

    Patients

    Seq Age Sex Outcome Treatment
    1 BD SYRINGE