BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DPS DRUCKMESS SET

    MDR report key: 1080106 · Received July 17, 2008

    Report

    Report Number
    1526863-2008-00024
    Event Type
    Malfunction
    Date Received
    July 17, 2008
    Date of Event
    February 28, 2008
    Report Date
    June 17, 2008
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    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

    THE SUBASSEMBLY IN QUESTION IS MFG BY SMITHS MEDICAL. THIS ASSEMBLY IS INCORPORATED INTO THE FINISHED PROD BY SMITHS MEDICAL INTL IN ANOTHER COUNTRY. THE FINISHED PROD IS FURTHER ASSEMBLED, PACKAGED AND STERILIZED BY SMITHS MEDICAL INTL. TWO SUBASSEMBLIES WERE REC'D. BOTH THE MALE LUER LOCK (MLL) AND FEMALE LURE LOCK (FLL) WERE MISSING FROM THE TUBING ON ONE SAMPLE. THE SECOND UNIT WAS MISSING THE FLL. EXAMINATION OF THE DISCONNECTION AREAS OF BOTH SAMPLES SHOWED THE TUBING HAD BEEN FULLY INSERTED AND ADHESIVE HAD BEEN APPLIED. THE TUBING DIAMETER WAS WITHIN SPEC. THERE WERE NO MFG ISSUES NOTED THAT WOULD HAVE CONTRIBUTED TO THE DISCONNECTIONS. THE TUBING ASSEMBLY IN QUESTION WAS MFG ON AN AUTOMATIC TUBING ASSEMBLY MACHINE. THE PROD IS 100% VISUALLY INSPECTED BY THE OPERATOR FOR PROPER ASSEMBLY AND SUFFICIENT SOLVENT. AS PART OF THE INSPECTION PROCESS ANY UNITS REMOVED DURING THE 100% WERE REWORKED BY THE OPERATOR. AS A PRECAUTION IN MID 2007, THIS PRACTICE HAS BEEN DISCONTINUED. ANY UNITS REMOVED DURING THE 100% INSPECTION ARE BEING DISCARDED. SMITHS WAS ABLE TO CONFIRM THE ISSUE; HOWEVER, NO ROOT CAUSE COULD BE DETERMINED. NO ADD'L ACTION IS NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT.

    Description of Event or Problem · 1

    ANOTHER COUNTRY, REPORTED TO SMITHS MEDICAL INTL THAT THE ARTERIAL PRESSURE LINE DETACHED FROM THE LUER LOCK ON THE STOPCOCK. THIS WAS FOUND AFTER 48 HRS IN USE. THERE WAS NO PT INJURY OR TREATMENT REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DPS DRUCKMESS SET PRESSURE MONITORING SET DRS SMITHS MEDICAL ASD, INC. NA 1201439

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK