BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN

    MDR report key: 2042545 · Received April 6, 2011

    Report

    Report Number
    2210968-2011-00390
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 9, 2011
    Manufacturer
    NI
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. A FUNCTIONAL TEST DONE WHERE A SYRINGE WITH WATER WAS ATTACHED TO THE ADAPTER AND INFUSED SOME WATER INSIDE THE DRAIN AND NOTICED DIFFICULTY IN WATER PASSAGE THROUGH THE DRAIN. INSIDE THE DRAIN, MAJOR DRY BLOOD CLOTS WERE OBSERVED AND WERE PARTLY STUCK INSIDE THE 1/8 ADAPTER. WHEN THE CLOTS WERE TAKEN OUT, THE WATER PASSED FREE THROUGH THE DRAIN AND ADAPTER. CONCLUSION: THE DEVICE INFORMATION FOR USE WARNS THAT AN EFFECTIVE CLOSED SUCTION DRAIN SYSTEM REQUIRES MAINTENANCE OF THE SYSTEM TO PRESERVE PATENCY. THE DRAIN MUST NOT BE ALLOWED TO OCCLUDE NOR THE RESERVOIR TO COMPLETELY FILL, AND RESERVOIR SUCTION MUST BE MAINTAINED.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/06/2011. (B)(4) - FAILURE TO DRAIN. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BRAIN TUMOR RESECTION PROCEDURE ON (B)(6) 2011. THE DRAIN WHICH WAS CONNECTED TO A 300ML RESERVOIR WAS PLACED UNDER THE SKIN AT THE RIGHT HEAD. THE DRAIN COULD NOT SUCTION WHEN THE RESERVOIR WAS UNLOCKED. THE DRAIN WAS PULLED FROM THE RESERVOIR AND CONNECTED TO A SYRINGE AND SUCTION WAS APPLIED BUT THE SAME EVENT OCCURRED. THEN THE SURGEON MADE A SPACE BETWEEN THE BONE AND THE MUSCLE WITH SUCTION TUBE, BUT THE DRAIN COULD NOT SUCTION. THE SURGEON SUBSTITUTED THE 15FR DRAIN FOR THE 10FR DRAIN THEN IT WORKED NORMALLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAKE DRAIN WOUND DRAINAGE SYSTEM KOG NI NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1