BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGICAL 84" SINGLE MONITORING LINE

    MDR report key: 1080104 · Received July 17, 2008

    Report

    Report Number
    1526863-2008-00025
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    May 22, 2008
    Report Date
    June 17, 2008
    Manufacturer
    SMITHS MEDICAL
    Product Code
    DRS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT #: 1222663. ADD'L EXP DATE: 10/2012. LOT 1222662 MFG 09/07, LOT 1222663 MFG 10/07. THE SUBASSEMBLY IN QUESTION IS A566 AND IS MFG BY SMITHS MEDICAL. THIS ASSEMBLY IS INCORPORATED INTO THE FINISHED PROD BY SMITHS MEDICAL. THE FINISHED PROD IS FURTHER ASSEMBLED, PACKAGED AND STERILIZED BY SMITHS MEDICAL. TWO A566 SUBASSEMBLIES WERE REC'D WITH THE MALE LUER LOCK (MLL) DISCONNECTED FROM THE TUBING. THE MISSING MLLS WERE NOT INCLUDED WITH THE SAMPLES. VISUAL EXAMINATION NOTED A YELLOW DISCOLORATION OF THE TUBING WHERE THE MLL HAD BEEN ATTACHED. THE DISCOLORATION EXTENDED BACK 1 TO 1 AND 1/2 INCHES FROM THE TUBING END. THE DISCOLORATION IS INDICATIVE OF AN ATTACK EITHER FROM FLUIDS BEING INFUSED WITHIN THE TUBING OR FROM THE ENVIRONMENT SUCH AS A HEAT SOURCE. EXAMINATION OF THE SOLVENT RING ON THE TUBING INDICATED THAT THE TUBING HAD BEEN FULLY SEATED INTO THEIR CORRESPONDING CONNECTORS AND SOLVENT APPLIED. THE TUBING MEASURED WITHIN SPEC. THERE WERE NO MFG ISSUES NOTED. SMITHS WAS ABLE TO CONFIRM THE ISSUE; HOWEVER, NO ROOT CAUSE COULD BE DETERMINED WITHOUT EXAMINATION OF THE MISSING MLL. THIS ISSUE IS BEING MONITORED. NO ADD'L ACTION IS NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT.

    Description of Event or Problem · 1

    FACILITY REPORTED TO SMITHS MEDICAL THAT THE LUER AT THE ARTERIAL SIDE DETACHED FROM THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOGICAL 84" SINGLE MONITORING LINE PRESSURE MONITORING SET DRS SMITHS MEDICAL NA 1222662

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK