BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J-VAC RESERVOIRS

    MDR report key: 4932710 · Received July 22, 2015

    Report

    Report Number
    2210968-2015-08951
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    June 30, 2015
    Report Date
    June 30, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    KOG
    PMA / PMN Number
    K953655
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE FLUID CAME OUT OF THE RESERVOIR EXIT PORT. THE NURSING STUDENT UNDERWENT IRRIGATION FOR EYES AND ANTIMICROBIAL-CONTAINING EYE DROP WAS PRESCRIBED. THE NURSING STUDENT IS BEING FOLLOWED UP FOR INFECTION STATUS. (B)(4). 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. BATCH JT8175; MFG. DATE: 12/18/2014; EXP DATE: 12/2019. BATCH JT8166; MFG. DATE: 01/13/2015; EXP DATE: 01/2020.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION CODE: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH # JT8175, BATCH # JT8186.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTROENTEROLOGICAL PROCEDURE ON (B)(6) 2015 AND A DRAIN WITH A RESERVOIR WAS USED. FOLLOWING THE PROCEDURE, A NURSE DRAINED WASTE FLUID AND PUSHED THE RESERVOIR TO LOCK. SOME OF THE PATIENT¿S BODY FLUID REMAINED AROUND THE DRAINAGE PART AND WAS SCATTERED AND GOT INTO EYES OF NURSING STUDENT WHO WAS ON THE OPPOSITE SIDE OF THE PATIENT¿S BED. THE PATIENT HAS (B)(6) AND THERE IS A POSSIBILITY OF BLOOD INFECTION FOR THE STUDENT. NO BLOOD INFECTION WAS CONFIRMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474849 J-VAC RESERVOIRS WOUND DRAINAGE SYSTEM KOG ETHICON INC. UNK JT8175

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention