BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOPCOCK IN BLISTER PACK

    MDR report key: 1850553 · Received October 1, 2010

    Report

    Report Number
    6000001-2010-03706
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. A FOLLOW UP MEDWATCH WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4)

    Description of Event or Problem · 1

    THIS IS A REPORT FROM BAXTER (B)(4) OF SOME CRACKS ON THE STOPCOCK BODY THAT WERE NOTICED DURING USE CAUSING THE BLOOD TO LEAK OUT OF THE CRACKS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOPCOCK IN BLISTER PACK STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - MALTA 08D16V046

    Patients

    Seq Age Sex Outcome Treatment
    1