BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIR

    MDR report key: 2944407 · Received February 5, 2013

    Report

    Report Number
    2210968-2013-00826
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 17, 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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-00827. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THERE WERE NO OBVIOUS VISUAL PROBLEMS WITH THE RETURNED SAMPLE. THE RESERVOIR WAS CONNECTED TO TUBING AND IT WAS ACTIVATED TO CHECK THE SUCTION. THE RESERVOIR¿S FLUID FLOWED WELL AND IT WORKED AS EXPECTED. 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 A SURGICAL PROCEDURE ON (B)(6) 2013 AND A RESERVOIR WAS CONNECTED TO A DRAIN. WHEN THE RESERVOIR WAS ACTIVATED, THE RESERVOIR ONLY INFLATED A LITTLE BIT AND THEN DID NOT SUCTION AT ALL. THE SURGEON DEACTIVATED THE RESERVOIR AND LOWERED IT BELOW THE DRAIN AND THE PATIENT'S FLUID FLOWED INTO THE RESERVOIR. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49005 J-VAC RESERVOIR WOUND DRAINAGE SYSTEM KOG ETHICON, INC. NA JT7796

    Patients

    Seq Age Sex Outcome Treatment
    1