BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL HALF SET W/ SMARTSITE VALVE

    MDR report key: 1023788 · Received March 20, 2008

    Report

    Report Number
    9616567-2008-00020
    Event Type
    Malfunction
    Date Received
    March 20, 2008
    Date of Event
    October 11, 2007
    Report Date
    February 7, 2008
    Manufacturer
    SMITHS MEDICAL, ASD
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER INDICATED THAT THE PRODUCT WAS NOT AVAILABLE FOR RETURN. THE DEVICE HISTORY WAS REVIEWED WITH NO RELATED ISSUES FOUND. REVIEW OF THE COMPLAINT DATABASE FROM THE PREVIOUS 24 MOS INDICATES THIS IS THE ONLY REPORTED COMPLAINT FOR THIS PRODUCT CODE. SMITHS WAS UNABLE TO CONFIRM THE ISSUE OR DETERMINE A POSSIBLE CAUSE WITHOUT THE RETURN PRODUCT EVALUATION. THE ISSUE IS BEING MONITORED. NO ADDITIONAL ACTION IS NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT. SMITHS RECOGNIZES THAT THIS REPORT IS NOT BEING SUBMITTED WITHIN THE REQUIRED TIMEFRAME. MDR REPORTING DEADLINE BASED UPON THE DATE THE INFO WAS RECEIVED WAS MARCH 8, 2008. SMITHS CONTINUES TO BE COMMITTED TO REGULATORY COMPLIANCE AND WILL MAKE EVERY AFFORT TO ENSURE THAT THIS DOES NOT RECUR.

    Description of Event or Problem · 1

    THE REPORTER STATED, "CC TUBING BROKE AT THE SITE OF THE TUBING MEETING THE CONNECTOR; SHOULD NEVER DISCONNECT THERE. THIS WAS DICOVERED WHILE PRIMING THE TUBING THAT WAS CONNECTED TO PT." THERE WAS NO PT INJURY OR TREATMENT REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISTAL HALF SET W/ SMARTSITE VALVE FLUID ADMINISTRATION SET FPA SMITHS MEDICAL, ASD NA 1191372

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN