BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK CONTINU-FLO 3 PORTMANIFOLD 10 DPM NV

    MDR report key: 1871412 · Received October 15, 2010

    Report

    Report Number
    6000001-2010-04070
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 22, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FMG
    PMA / PMN Number
    K932512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CUSTOMER, THE ACTUAL SAMPLES ARE NOT AVAILABLE BUT COMPANION SAMPLES ARE AVAILABLE FOR EVALUATION. SAMPLES HAVE NOT YET BEEN RECEIVED BY BAXTER. A FOLLOW-UP REPORT WILL BE FILED IF THE SAMPLE IS RETURNED AND EVALUATED OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A CUSTOMER DID NOT SEND IN AN ACTUAL NOR COMPANION SAMPLE FOR EVALUATION; HOWEVER A SIMILAR PRODUCT WITH A DIFFERENT LOT NUMBER WAS SENT IN FOR EVALUATION. DURING THE VISUAL INSPECTION THE REPORTED CONDITION WAS CONFIRMED SINCE ONE UNIT HAD A SEPARATED CONDITION BETWEEN THE STOPCOCK WITH MALE LUER LOCK AND THE WINGED FEMALE LUER LOCK ADAPTER. THE CAUSE OF THIS CONDITION IS UNKNOWN; HOWEVER IT WAS MOST PROBABLY CAUSED BY A LUER DISCONNECTION. SINCE THIS JUNCTION IS MANUALLY ASSEMBLED THE UNIT WAS RE-ASSEMBLED. THE FUNCTIONAL TEST AND PRESSURE TEST AT 8PSI WAS PERFORMED WITH RESULTS THAT WERE SATISFACTORY. 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.

    Description of Event or Problem · 1

    ON SEPTEMBER 22, 2010, A CUSTOMER REPORTED A COMPLAINT REGARDING A CLEARLINK CONTINU-FLO SET, LOT # UNKNOWN, PRODUCT CODE 2C8931. THE CUSTOMER REPORTED THE SET WAS DIFFICULT TO SECURE TO THE MANIFOLD PORTION OF THE TUBING, WHICH CAUSED A LEAK WHILE IN USE NI THE OPERATING ROOM. IT IS UNKNOWN WHEN THIS INCIDENT OCCURRED. IF IS ALSO UNKNOWN IF THERE WAS ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. ACTUAL SAMPLES ARE NOT AVAILABLE BUT COMPANION SAMPLES ARE AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK CONTINU-FLO 3 PORTMANIFOLD 10 DPM NV STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1