BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC BULB RESERVOIR

    MDR report key: 2834614 · Received November 15, 2012

    Report

    Report Number
    2210968-2012-07366
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    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). ANTI-REFLUX VALVE DETACHMENT. 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 INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH J1227917; BATCH J1227920.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL PRODUCT WAS RECEIVED FOR EVALUATION. THE VALVE IS DETACHED AND INSIDE THE RESERVOIR. THE VALVE'S SLIT IS CLOSED. INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH # J1227917; MFG DATE 2012-03; EXPIRATION DATE 2017-03. BATCH J1227920; MFG DATE 2012-04; EXPIRATION DATE 2017-04. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VALVE REPLACEMENT PROCEDURE ON (B)(6) 2012 AND A RESERVOIR WAS CONNECTED TO THE DRAIN AT THE PERICARDIUM. ON (B)(6) 2012, THE STAFF FOUND THAT THE ANTI-REFLUX VALVE HAD DETACHED AND FELL INTO THE RESERVOIR. ANOTHER LIKE DEVICE WAS USED WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1