BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSTAR 84 IN SINGLE MONITORING KIT

    MDR report key: 1051205 · Received May 23, 2008

    Report

    Report Number
    9616567-2008-00041
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 23, 2008
    Manufacturer
    SMITHS MEDICAL, ASD
    Product Code
    DRS
    PMA / PMN Number
    K942377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIVE SAMPLES - 3 UNOPENED, UNUSED AND 2 USED - WERE RECEIVED. ALL CONNECTIONS ON THE 3 UNUSED SAMPLES WERE PULL TESTED UNTIL FAILURE. ALL CONNECTIONS FAILED BETWEEN 19.6LBS AND 24.9LBS OF FORCE. ALL CONNECTIONS PASSED THE MINIMUM 10LBS PULL FORCE. ALL SEPARATED CLEANLY WITHOUT TUBING BREAKAGE. EXAMINATION OF THE CONNECTIONS SHOWED THE CONNECTIONS HAD BEEN CORRECTLY BONDED AND FULLY INSERTED. THE TUBING WAS WITHIN SPEC. THERE WERE NO MFG DEFECTS OBSERVED. THE FIRST USED SAMPLE SHOWED JAGGED, BROKEN TUBING STILL ATTACHED INSIDE THE FEMALE LUER LOCK (LL). THE SECOND USED SAMPLE SHOWED THE TUBING STILL ATTACHED TO THE MALE LL, BUT THE TUBING HAD BEEN TORN OPEN FROM ABOVE THE MALE LL TO THE TUBING PORT WITH A SECTION OF THE TUBING PULLED AWAY FROM THE WALLS OF THE TUBING PORT. THE TUBING MEASURED WITHIN SPEC FOR BOTH SAMPLES. VISUAL OBSERVATION OF THE DAMAGE INDICATES NEITHER CONNECTION SEPARATED AND THAT THE TUBING WAS PULLED DURING USE UNTIL THE TUBING BROKE (FIRST SAMPLE) OR SPLIT (SECOND SAMPLE). NO MFG ISSUES WERE OBSERVED. THE DEVICE HISTORY WAS REVIEWED WITH NO ISSUES NOTED. SMITHS WAS ABLE TO CONFIRM THE ISSUE DUE TO DAMAGE DURING USE. NO ADD'L ACTION IS NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT TWO TRANSDUCERS FROM THE SAME LOT HAVE CRACKED TUBING. ONE WAS CRACKED BY THE CONNECTOR ON THE END. THE OTHER BY THE CONNECTOR THAT LEADS TO THE STOPCOCK WITH THE WHITE LEVER. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSTAR 84 IN SINGLE MONITORING KIT PRESSURE MONITORING KIT DRS SMITHS MEDICAL, ASD NA 1167138

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK