BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES

    MDR report key: 1821173 · Received August 31, 2010

    Report

    Report Number
    6000001-2010-02890
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    July 13, 2010
    Report Date
    August 6, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE SAMPLE IS AVAILABLE AT THIS TIME. A FOLLOW UP REPORT WILL BE FILED IF THE SAMPLE IS RETURNED AND EVALUATED OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. NO DEVIATIONS WERE FOUND IN THE BATCH REVIEW. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER INVESTIGATION, IT HAS BEEN DISCOVERED THAT MEDICAL DEVICE REPORT HAS ALREADY BEEN SUBMITTED FOR THIS CONDITION AS NOTED IN REPORT NUMBER 6000001-2010-01493. ALL NECESSARY INFORMATION IN REGARDS TO THE REPORTED CONDITION WILL BE NOTED IN THE REPORT MENTIONED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SAMPLE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A CUSTOMER RETURNED ONE ACTUAL SAMPLE OF THE CONTINU-FLO SOLUTION SET. VISUAL INSPECTION AND PULL TESTING WERE PERFORMED ON THE RETURNED SAMPLE AND A SEPARATION WAS NOTICED NEAR THE TUBING BONDING ASSEMBLY OF THE Y-SITE. THE ROOT CAUSE IS UNKNOWN AT THIS TIME. IN THE PREVIOUS MEDICAL DEVICE REPORT IT WAS MENTIONED THAT THIS REPORT WAS CREATED INADVERTENTLY AND THE ORIGINAL REPORT IS DOCUMENTED IN REPORT NUMBER 6000001-2010-01493. HOWEVER THIS REPORT IS THE ORIGINAL AND WAS NOT CREATED INADVERTENTLY.

    Description of Event or Problem · 1

    MEDWATCH RECEIVED FROM FACILITY STATED, NURSE OPENED PRIMARY IV TUBING AND FOUND THAT THE TUBING DISCONNECTED FROM ITSELF AT THE SECOND PORT. THE DEVICE WAS NOT USED ON A PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R10E03068

    Patients

    Seq Age Sex Outcome Treatment
    1