BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALKMED INFUSION IV ADMINISTRATION SET W/NEEDLEFREE Y-SITE & 0.22 MICRON FILTER

    MDR report key: 5700775 · Received June 6, 2016

    Report

    Report Number
    1723533-2016-00156
    Event Type
    Malfunction
    Date Received
    June 6, 2016
    Report Date
    May 9, 2016
    Manufacturer
    WALKMED INFUSION, LLC.
    Product Code
    FPA
    PMA / PMN Number
    K073444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THIS REPORT WAS ORIGINALLY SUBMITTED, WALKMED INFUSION ASSIGNED AN INCORRECT DEVICE PRODUCT CODE. CODE "FPB" WAS INCORRECTLY ASSIGNED, WHEN "FPA" WAS THE CORRECT CODE.

    Additional Manufacturer Narrative · 1

    THE EVALUATION FOR THE DEVICE IN QUESTION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED IN 30 CALENDAR DAYS TO DISCLOSE ANY FINDINGS FROM THE PRODUCT'S EVALUATION.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL PRODUCT EVALUATION INFORMATION HAS BEEN PROVIDED BY THE CONTRACT MANUFACTURER OF THIS PRODUCT. ON JUNE 14, 2016 WALKMED INFUSION INITIATED A VOLUNTARY MEDICAL DEVICE RECALL FOR THE TRITON AND TRITON FP INFUSION PUMPS (MODEL NUMBERS 300000 AND 400000). AS A RESULT OF THESE PRODUCTS BEING REMOVED FROM THE MARKET, ADDITIONAL INVESTIGATION WAS TERMINATED.

    Description of Event or Problem · 1

    WHILE PRIMING THE ADMINSTRATION SET IN QUESTION, THE SLIDE CLAMP BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357065 WALKMED INFUSION IV ADMINISTRATION SET W/NEEDLEFREE Y-SITE & 0.22 MICRON FILTER INTRAVASCULAR ADMINISTRATION SET WITH FILTER FPA WALKMED INFUSION, LLC. 1508010D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other