BEUDAMED
    FDA Adverse Event Death Summary report: N

    BACTISEAL CL EVE 1.9 CATHETER SET

    MDR report key: 4194008 · Received October 22, 2014

    Report

    Report Number
    1226348-2014-12068
    Event Type
    Death
    Date Received
    October 22, 2014
    Date of Event
    October 3, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK021653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS HAVE BEEN CONDUCTED AND THEY REVEALED THAT THE DEVICE CONFORMED TO ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. IF AT SOME POINT THE DEVICE IS RETURNED FOR EVALUATION THIS COMPLAINT WILL BE RE-OPENED AND INVESTIGATED. BASED ON THIS EVALUATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2014 A CATHETER (821750, LOT519532) WAS IMPLANTED IN THE PATIENT. THIS CATHETER WAS CONNECTED TO A EDS3 SYSTEM (821731, LOTCRDDF9). ON (B)(6) A NEW CATHETER (821750, LOT528914) WAS IMPLANTED AND CONNECTED TO A NEW EDS3 SYSTEM (821731, LOTCRFCVN). AT THIS MOMENT THE PATIENT GOT SERIOUSLY ILL AND PASSED AWAY (DATE TO BE VERIFIED). THE HOSPITAL IDENTIFIED THE SOURCE OF THE INFECTION: KLEBSIELLA OXYTOCA. PLEASE NOTICE WE ALSO SUBMITTED A VERY SIMILAR COMPLAINT ((B)(4)), WITH THE SAME INFECTION KLEBSIELLA OXYTOCA. ADDITIONAL INFORMATION RECEIVED: THE HOSPITAL INFORMED US TODAY THAT THE DEVICES ARE NOT AVAILABLE FOR INVESTIGATION. THEY ALSO INFORMED US THAT THE SECOND OPERATION WAS PERFORMED BECAUSE THE PATIENT HAD A FEVER DUE TO THE INFECTION. THE PATIENT PASSED AWAY ON (B)(6), BUT THE HOSPITAL ONLY INFORMED OUR PRODUCT SPECIALIST AND FRANCHISE MANAGER LAST FRIDAY THE (B)(6). BECAUSE OF THE SERIOUSNESS OF THIS COMPLAINT, THE HOSPITAL WOULD LIKE TO GET A BATCH RECORD REVIEW AS SOON AS POSSIBLE. ANY IDEA ON THE TIME-FRAME OF THIS INVESTIGATION?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673124 BACTISEAL CL EVE 1.9 CATHETER SET SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC 519532

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 82-1731| 82-1750| 82-1731