BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRASITE VALVE NEEDLELESS SYSTEM

    MDR report key: 3932251 · Received April 4, 2014

    Report

    Report Number
    2523676-2014-00088
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    February 27, 2014
    Report Date
    March 11, 2014
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K031923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B BRAUN MEDICAL INC. (B)(4). ONE USED ULTRASITE VALVE, WITHOUT PACKAGING, WAS RECEIVED FOR EVAL. THE HUBER NEEDLE TUBING, THAT WAS REPORTED TO BE CONNECTED TO THE VALVE, WAS NOT RETURNED. NO ABNORMALITIES OR ANOMALIES WERE VISUALLY OBSERVED ON THE ULTRASITE VALVE. THE VALVE WAS THEN SUBJECTED TO FLOW AND WATER PRESSURE (LEAKAGE) TESTING ACCORDING TO SPECIFICATION WITH ACCEPTABLE RESULTS. THERE WAS NO LEAKAGES OBSERVED WITHIN THE VALVE OR AT THE LUER CONNECTORS DURING THE TESTING TIME FRAME. THE RETURNED SAMPLE MET REQUIREMENTS ACCORDING TO SPECIFICATION, AND THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE REPORTING FACILITY DID INDICATE THAT THE NURSE MAY NOT HAVE TIGHTENED THE ULTRASITE. IT IS INDICATED ON THE INSTRUCTIONS FOR USE (IFU) FOR THE REPORTED PRODUCT CATALOG NUMBER TO "FIRMLY ATTACH INJECTION SITE TO DESIRED CONNECTION." NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER. IF ADD'L PERTINENT INFO BECOMES AVAILABLE, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS DURING INFUSION OF BICARB AND CHEMO, LEAKAGE OCCURRED AT THE CONNECTION BETWEEN THE HUBER NEEDLE TUBING AND ULTRASITE VALVE CAUSING A CHEMO SPILL. THE RN MANAGER STATED THE NURSE MAY NOT HAVE TIGHTENED THE ULTRASITE AND IT BEGAN LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205498 ULTRASITE VALVE NEEDLELESS SYSTEM ULTRASITE VALVE FPA B. BRAUN MEDICAL, INC. CSU100 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HUBER NEEDLE TUBING