BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSTAR 72 IN DOUBLE MONITORING KIT

    MDR report key: 898780 · Received August 16, 2007

    Report

    Report Number
    9616567-2007-00019
    Event Type
    Malfunction
    Date Received
    August 16, 2007
    Report Date
    July 17, 2007
    Manufacturer
    SMITHS MEDICAL
    Product Code
    DRS
    PMA / PMN Number
    K942377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION CONFIRMED THE TUBE HAD BROKEN AWAY FROM THE FEMALE LUER LOCK (FLL) WITH A VISIBLE V-SHAPED TEAR. THE BREAK WAS SHINY IN APPEARANCE ON THE TOP OF THE TUBE SURFACE BECOMING JAGGED IN APPEARANCE AT THE BOTTOM OF THE V-SHAPED TEAR. THERE WAS EVIDENCE OF SOLVENT ON THE TOP OF THE TORN SECTION INDICATING THAT THE BREAKAGE OCCURRED BELOW THE SOLVENT CONNECTION INTO THE FLL AND THAT THE BOND INTO THE FLL WAS ACCEPTABLE. NO ROOT CAUSE FOR THE BREAK COULD BE DETERMINED; HOWEVER, THE NATURE OF THE BREAKAGE SUGGESTS THAT IT COULD HAVE RESULTED FROM SOME TYPE OF SHOCK. THE DEVICE HISTORY WAS REVIEWED WITH NO ISSUES PRESENT. REVIEW OF THE COMPLAINT DATABASE INDICATES THIS IS THE ONLY REPORTED BREAKAGE ISSUE FOR THIS PRODUCT CODE IN THE PAST 24 MONTHS. SMITHS WAS ABLE TO CONFIRMED THE ISSUE AND DETERMINE A POSSIBLE CAUSE. THIS 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 END OF A CATHETER (LUMEN) IS BROKEN AND DETACHED FROM THE PRESSURE TRANSDUCER. THERE WAS NO PATIENT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSTAR 72 IN DOUBLE MONITORING KIT PRESSURE MONITORING KIT DRS SMITHS MEDICAL NA 36H29M056

    Patients

    Seq Age Sex Outcome Treatment
    1 YR