BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN

    MDR report key: 2933438 · Received January 29, 2013

    Report

    Report Number
    2210968-2013-00635
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 7, 2013
    Manufacturer
    ETHICON, INC.
    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). 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.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. ONE OF THE TUBE EDGES WAS BROKEN AND VERY UNEVEN. THE DRAIN COULD BE SLIGHTLY DAMAGED BY THE END USER AND LATER BROKE IN THIS AREA. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CRANIOTOMY ON (B)(6) 2012 AND A DRAIN WAS INSERTED. ON (B)(6) 2013, WHILE THE NURSE WAS MILKING THE DRAIN, IT WAS NOTED THAT THE DRAIN WAS BROKEN OUTSIDE OF THE PATIENT'S BODY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39225 BLAKE DRAIN WOUND DRAINAGE SYSTEM KOG ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1