BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIDS KIT (TM) MONITORING/SAMPLING UA LINE

    MDR report key: 892977 · Received August 10, 2007

    Report

    Report Number
    9616567-2007-00015
    Event Type
    Malfunction
    Date Received
    August 10, 2007
    Report Date
    July 12, 2007
    Manufacturer
    SMITHS MEDICAL
    Product Code
    DQO
    PMA / PMN Number
    K902771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION CONFIRMED THE TUBE WAS DISCONNECTED FROM THE FEMALE LUER LOCK (FLL). THERE WAS EVIDENCE OF UNIFORM CHEMICAL ATTACK OF SOLVENT ON THE TUBE WHERE THE FLL WAS BONDED. THE OD OF THE TUBE AND THE ID OF THE FLL WERE WITHIN SPECIFICATION. THE DEVICE HISTORY COULD NOT BE REVIEWED WITHOUT A REPORTED LOT NUMBER AS A REFERENCE. REVIEW OF THE COMPLAINT DATABASE FOR THE PREVIOUS 24 MONTHS INDICATES THIS IS THE SECOND REPORTED DISCONNECTION ISSUE FOR THIS PRODUCT CODE. SMITHS WAS ABLE TO CONFIRM THE ISSUE; HOWEVER, NO ROOT CAUSE COULD BE DETERMINED. THE ISSUE IS BEING MONITORED FOR TREND. NO ADDITIONAL ACTION IS NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE TUBING FELL OUT OF THE CONNECTOR THAT ATTACHES TO THE SYRINGE. THERE WAS NO PATIENT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIDS KIT (TM) MONITORING/SAMPLING UA LINE CLOSED BLOOD SAMPLING KIT DQO SMITHS MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR