BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOGICAL 60" SINGLE LINE MONITORING KIT

    MDR report key: 956786 · Received November 29, 2007

    Report

    Report Number
    1526863-2007-00047
    Event Type
    Malfunction
    Date Received
    November 29, 2007
    Report Date
    November 1, 2007
    Manufacturer
    SMITHS MEDICAL
    Product Code
    DRS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBASSEMBLY IN QUESTION IS A561 AND IS MANUFACTURED BY SMITHS MEDICAL ASD. THIS ASSEMBLY IS INCORPORATED INTO THE FINISHED PRODUCT BY SMITHS MEDICAL INTERNATIONAL. THE FINISHED PRODUCT IS FURTHER ASSEMBLED, PACKAGED AND STERILIZED BY SMITHS MEDICAL INTERNATIONAL. ONE A561 SUBASSEMBLY WITH THE TUBE SEPARATED FROM THE FLL AND ONE A561 WITH THE FLL MISSING WERE RECEIVED. THE TUBING SEPARATED FROM THE FLL WAS MEASURED AND WAS WITHIN SPECIFICATION. OBSERVATION OF THE SOLVENT RING INDICATED THAT THE SOLVENT HAD BEEN APPLIED AND THE TUBING HAD BEEN INSERTED TO THE CORRECT DEPTH AND FULLY SEATED. NO ROOT CAUSE FOR THE SEPARATION COULD BE DETERMINED. THE SECOND A561 WAS RECEIVED IN A CONDITION WHICH PREVENTED FURTHER ANALYSIS. SMITHS WAS ABLE TO CONFIRM THE ISSUE; HOWEVER, NO ROOT CAUSE COULD BE DETERMINED. CAPA HAS BEEN ISSUED TO FURTHER INVESTIGATE THIS ISSUE. NO ADDITIONAL ACTION IS NECESSARY AT THIS TIME. SMITHS CONSIDERS THIS MDR CLOSED WITH THIS REPORT.

    Description of Event or Problem · 1

    INTERNATIONAL AFFIILIATE REPORTED TO SMITHS MEDICAL INTERNATIONAL, THAT THE JOINT SEPARATED AT THE ARTERIAL SIDE OF THE TUBING. THERE WAS NO PATIENT INJURY OR TREATMENT REPORTED WITH THIS 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 NA 1171824

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR