BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN BACTISEAL EVD CATHETER

    MDR report key: 4276221 · Received November 25, 2014

    Report

    Report Number
    1226348-2014-12117
    Event Type
    Injury
    Date Received
    November 25, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK021653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN FOR EVALUATION. HOWEVER, THE CUSTOMER RETURNED EIGHT PRODUCTS P/N 82-1745 WITH THE FOLLOWING LOT NUMBERS: CRCBM1 - 1 EA. CRCBM3 - 1 EA. CRDCR2 - 1 EA. CRJB8N - 5 EA. THE BROKEN DEVICES WERE NOT RETURNED, BUT 8 NEW DEVICES WERE RETURNED FOR EVALUATION TO CODMAN SWITZERLAND. THE INVESTIGATION OF THE RETURNED DEVICES DID NOT CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBERS ARE: CRCBM1, PRODUCT CODE 82-1745, 1 DEVICE RETURNED. CRCBM3, PRODUCT CODE 82-1745, 1 DEVICE RETURNED. CRDCR2, PRODUCT CODE 82-1745, 1 DEVICE RETURNED. CRJB8N, PRODUCT CODE 82-1745, 5 DEVICES RETURNED. THE WHITE PLASTIC SQUARE CONNECTORS WERE EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION. NO CRACKS OR BRAKES IN THE DEVICES WERE FOUND. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-1745 WITH LOT CRCBM1, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 7TH APRIL 2014. EXPIRY DATE 31ST DECEMBER 2014. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-1745 WITH LOT CRCBM3, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 3RD MARCH 2014. EXPIRY DATE 31ST DECEMBER 2014. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-1745 WITH LOT CRDCR2, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 28TH APRIL 2014. EXPIRY DATE 31ST JANUARY 2015. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-1745 WITH LOT CRJB8N, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 18TH AUGUST 2014. 30TH JUNE 2015. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    E-MAIL RECEIVED FROM THE SALES REP/CUSTOMER INFORMED THAT: "WE HAVE HAD 2 OF THE CODMAN ANTIBIOTIC COATED CATHETERS LEAK WITHIN THE PAST 2 WEEKS. THERE ARE TINY CRACKS IN THE WHITE PLASTIC PIECE THAT IS CLOSEST TO THE INSERTION INTO THE PATIENT. WE ARE CONSIDERING PULLING THEM OUT OF SERVICE, BUT I NEED TO MAKE SURE THERE ARE ALTERNATIVES AVAILABLE BECAUSE IT WOULD BE A SYSTEM WIDE PULL. MATERIALS IS INVESTIGATING, BUT WE HAVE ALREADY HAD ONE OF THESE PATIENTS DEVELOP VENTRICULITIS (YEAST)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764238 CODMAN BACTISEAL EVD CATHETER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention