BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    J-VAC RESERVOIR

    MDR report key: 2260626 · Received September 22, 2011

    Report

    Report Number
    2210968-2011-01356
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 1, 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) ANTI-REFLUX VALVE DETACHMENT. THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. THE ANTI-REFLUX VALVE WAS DETACHED. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH J1101590 MFG DATE: 02/01/2011, EXP DATE: 02/28/2016; BATCH J1022261 MFG DATE: 01/01/2010, EXP DATE: 02/28/2015; BATCH J1100779 MFG DATE: 01/01/2011, EXP DATE: 01/31/2016. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH J1101590, BATCH J1022261 MFG DATE: 01/01/2010, EXP DATE: 02/28/2015, BATCH J1100779. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBER J1022261 WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFTING PROCEDURE ON (B)(6) 2011 AND A DRAIN WAS PLACED. UPON INITIAL ACTIVATION OF THE RESERVOIR, IT WAS FOUND THAT THE ANTI-REFLUX VALVE HAD BEEN DETACHED AND FALLEN INTO THE RESERVOIR WHEN THE SURGEON TRIED TO SUCTION. IT IS UNKNOWN IF ANOTHER DEVICE WAS USED. THERE WAS NO ADVERSE PATIENT CONSEQUENCES. THE CURRENT CONDITION OF THE PATIENT IS STABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1