BEUDAMED
    FDA Adverse Event Other Summary report: N

    DTX PLUS

    MDR report key: 1652386 · Received April 1, 2010

    Report

    Report Number
    8020616-2010-00005
    Event Type
    Other
    Date Received
    April 1, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 5, 2010
    Manufacturer
    BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD
    Product Code
    DXN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: VISUAL EXAMINATION ON THE RETURNED DEVICE SHOWED THAT THE MANIFOLD IS POSITIONED AT 45 DEGREE. FUNCTIONAL TEST CONDUCTED SHOWS THAT WHEN FAST FLUSH WAS PERFORMED, PRESENCE OF AIR IN THE TUBING LINE WAS OBSERVED WHEN THE MANIFOLD IS AT 45 DEGREE. UPON POSITIONING THE MANIFOLD AT 90 DEGREE FOR "OFF" DIRECTION, NO AIR WAS OBSERVED IN THE TUBING LINE. A REVIEW OF THE BATCH DOCUMENTATION, WHICH INCLUDES DEVICE HISTORY RECORDS AND INSPECTION REPORTS, SHOWED THAT NO PROBLEMS WERE FOUND RELATING TO DAMAGED DEVICE AND WRONG ASSEMBLY DURING MANUFACTURING PROCESS. CONCLUSION: THE WRONG ORIENTATION OF MANIFOLD COULD BE DUE TO: WRONG ORIENTATION OF MANIFOLD FROM SUPPLIER MANUFACTURING PROCESS THAT WAS NOT DETECTED DURING THEIR QUALITY INSPECTION. PRODUCTION ASSOCIATES DURING ASSEMBLY AND PACKAGING PROCESS DID NOT DETECT THE WRONG ORIENTATION OF THE MANIFOLD. USER PERFORMING THE KIT SET-UP, POSITIONED THE MANIFOLD AT 45 DEGREE AS "OFF" DIRECTION. (B)(4).

    Description of Event or Problem · 1

    AIR WAS INTRODUCED INTO THE STOPCOCKS WHEN CONNECTED TO SHEENMAN STOPCOCK (CURRENTLY THIS STOPCOCK IS INVESTIGATED IN SHEENMAN) AND AIR WAS NOT ABLE TO BE RETRIEVED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DTX PLUS BLOOD PRESSURE TRANSDUCER DXN BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD NA 911404

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other