BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIR

    MDR report key: 2120595 · Received June 10, 2011

    Report

    Report Number
    2210968-2011-00748
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ETHICON
    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 2210968-2011-00747. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND FUNCTIONALLY EVALUATED. THE RESERVOIR WAS TESTED AS FOLLOWS: THE PLATE WAS UNLOCKED AND EXIT AND ENTRANCE PORTS WERE PLUGGED, THE RESERVOIR WAS PLACED UNDERWATER AND PRESSED BY HAND TO CONFIRM IF THERE WERE ANY LEAKAGE AND THE RESULT WAS: NO LEAKAGE WAS OBSERVED DURING THE TEST THAT MIGHT PRODUCE THIS DEFECT. CONCLUSION: NO DEVICE FAILURE DETECTED AND THE PRODUCT IS WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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 MASTECTOMY ON (B)(6), 2011 AND TWO 10FR DRAINS AND A RESERVOIR WERE PLACED. AFTER THE SURGERY ON (B)(6), 2011, THE FLUID IN THE RESERVOIR WAS DISPOSED OF AND WHEN THE RESERVOIR WAS RE-ACTIVATED, THE RESERVOIR INFLATED ON THE LEFT SIDE ONLY. THE PATIENT FLUID COLLECTED IN THE RESERVOIR. THERE WAS NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J-VAC RESERVOIR WOUND DRAINAGE SYSTEM KOG ETHICON NA JT7550

    Patients

    Seq Age Sex Outcome Treatment
    1