BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC BULB RESERVOIR

    MDR report key: 3142272 · Received June 3, 2013

    Report

    Report Number
    2210968-2013-06376
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 8, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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

    (B)(4). THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE DEVICE PERFORMED ACCORDING TO SPECIFICATION. THE RESERVOIR WAS TESTED FOR FUNCTIONALITY AND WAS FOUND TO BE FULLY FUNCTIONAL.

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2013 AND A RESERVOIR WAS USED. WHEN ACTIVATING THE DEVICE, IT HAD INADEQUATE SUCTION. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243360 J-VAC BULB RESERVOIR WOUND DRAINAGE SYSTEM KOG ETHICON, INC NA J1227921

    Patients

    Seq Age Sex Outcome Treatment
    1