BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC BULB RESERVOIR

    MDR report key: 3072482 · Received April 23, 2013

    Report

    Report Number
    2210968-2013-04277
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PROCEDURE WAS AN UMBILICAL HERNIA REPAIR PROCEDURE. THE RESERVOIR INFLATED QUICKLY UPON ACTIVATION. THERE WAS NO LEAKAGE DETECTED. ANOTHER LIKE DEVICE WAS USED WITH NO ADVERSE PATIENT CONSEQUENCES. CURRENTLY, THE PATIENT IS IN GOOD HEALTH.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. ONE RESERVOIR WITH THE AR VALVE DETACHED AND INSIDE OF THE RESERVOIR WAS RETURNED. THE VALVE LOOKS DETERIORATED AND HAD SHRUNK, THE IS SLIT IS CLOSED. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4) - INADEQUATE SUCTION. 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 AN UNKNOWN PROCEDURE ON (B)(6) 2013 AND A RESERVOIR WAS USED. IT WAS NOTED THAT AFTER THE PROCEDURE THE RESERVOIR DID NOT SUCTION. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173926 J-VAC BULB RESERVOIR WOUND DRAINAGE SYSTEM KOG ETHICON, INC. NA J1236140

    Patients

    Seq Age Sex Outcome Treatment
    1