BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGICAL 60" SINGLE LINE MONITORING KIT

    MDR report key: 1033503 · Received April 2, 2008

    Report

    Report Number
    1526863-2008-00012
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    February 10, 2008
    Report Date
    March 3, 2008
    Manufacturer
    SMITHS MEDICAL ASD
    Product Code
    DRS
    PMA / PMN Number
    k820355
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE STOPCOCK AND ONE SAMPLE OF TUBING WERE REC'D. THE STOPCOCK WAS DETACHED FROM THE DOME. THE TUBING WAS REC'D WITH A FEMALE CONNECTOR AT ONE END AND BREAK AT THE OPPOSITE END AND 3 INCHES IN LENGTH MISSINGTHE STOPCOCK SHOWED EVIDENCE THAT IT HAD BEEN PROPERLY BONDED AND FULLY SEATED INTO THE CONNECTOR. NO BREAKAGE OR MANUFACTURING ISSUES WERE NOTED. THE BROKEN END OF THE TUBING SHOWED A ROUGH, UNEVEN SURFACE. THIS IS CONSISTENT WITH BEING TORN WITH ENOUGH FORCE TO BREAK THE TUBING. NO MANUFACTURING ISSUES WERE NOTED. THREE UNUSED, UNOPENED SAMPLES FROM THE REPORTED LOT WERE ALSO REC'D FROM THE CUSTOMER. CONNECTIONS AT THE FEMALE LUER LOCK ALL EXCEEDED 18LBS FORCE DURING PULL TESTING FOR ALL 3 SAMPLES (SPEC IS >10LBS). CONNECTIONS AT THE MALE LURE LOCK EXCEEDED 17 LBS FORCE DURING PULL TESTING FOR ALL THREE SAMPLES (SPEC IS >10LBS). ALL BONDED CONNECTIONS WERE SECURE AND WELL EXCEEDED 10LB PULL TEST SPECIFICATION. REVIEW OF THE DEVICE HISTORY WAS PERFORMED AND FOUND TO BE ACCEPTABLE. SMITHS WAS ABLE TO CONFIRM THIS ISSUE AND DETERMINE THE PROBABLE CAUSE. BOTH PARTS SHOW SOME EVIDENCE THAT THEY HAD BEEN PULLED BEYOND THE BREAKING POINT DURING USE. NO ADD'L ACTION NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING A DRESSING CHANGE, BLOOD WAS OBSERVED BACKING UP IN THE ATRIAL LIFE PRESSURE TUBING. THE TUBING WAS FRACTURED AT THE MANIFOLD. APPROX 20ML OF BLOOD WAS LOST. THERE WAS NO PT INJURY OR TREATMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOGICAL 60" SINGLE LINE MONITORING KIT PRESSURE MONITORING SET DRS SMITHS MEDICAL ASD NA 1147063

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR