BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EXTERNAL DRAINAGE SYSTEM III

    MDR report key: 4093736 · Received September 16, 2014

    Report

    Report Number
    1226348-2014-11976
    Event Type
    Injury
    Date Received
    September 16, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 NOT RETURNED.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT SAMPLE WAS NOT RETURNED TO CODMAN AND PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE EVALUATION COULD NOT BE PERFORMED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. COMPLAINT IS CONSIDERED CLOSED AT THIS TIME. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IN A VOICE MAIL IT WAS REPORTED THAT THE TUBING CAME APART AT THE JUNCTION OF THE STOPCOCK WITH THE PATIENT LINE (I BELIEVE THAT THIS IS THE FIRST STOPCOCK FROM THE PATIENT) IN THREE DIFFERENT INCIDENTS. TWO OF INCIDENTS OCCURRED LAST WEEK AND THE THIRD ONE (B)(6) 2014. NO COMPLAINT SAMPLES ARE AVAILABLE TO BE RETURNED TO CODMAN FOR EVALUATION. UNFORTUNATELY, I DON¿T HAVE PATIENT INFORMATION FOR ANY OF THE (3) INSTANCES. FOR ALL (3), CLINICIANS JUST PULLED ANOTHER DRAIN, AND RECONNECTED A NEW DRAIN TO THE DRAINAGE CATHETER. NO CATHETERS WERE REVISED. PATIENTS ARE ALL DOING FINE. NO ADDITIONAL CONCERNS AROSE DUE TO REVISING THE EDS3 SO FAR. I WAS INFORMED THE EVENING OF (B)(6) 2014 EVENTS WERE OVER THE (B)(6). TWO WERE WITH NEURO RESIDENT (B)(6), AND (1) WAS ON (B)(6) WITH NURSE PRACTITIONER (B)(6). I HAVE ATTACHED A PICTURE OF (B)(6) BUSINESS CARD SO YOU HAVE HER CONTACT INFORMATION. I DID LEAVE A MESSAGE FOR (B)(6) TO TRY TO GET MORE INFORMATION ON THE COMPLAINT, BUT HAVE NOT HEARD BACK FROM HER. I DO NOT HAVE PRODUCT TO RETURN, NOR DO I HAVE ANY LOT NUMBER INFORMATION. I HAD CUSTOMER SERVICE RUN A SALES REPORT. NOTHING SHOWS AS FAR AS EDS3 DRAIN CODES, SO IT MAKES ME THINK THAT THIS PRODUCT COMES THROUGH DISTRIBUTION CHANNELS. (B)(6) IS CURRENTLY ON MATERNITY LEAVE, AND THIS IS HER ACCOUNT. (B)(6) ARE HELPING ME TO COVER THINGS IN (B)(6). I HAVE THE CLINICIANS ON HIGH ALERT TO TAKE PICTURES, SAVE PRODUCT AND PROVIDE LOT NUMBERS IF POSSIBLE NEXT TIME THIS OCCURS. SEE ALL RELATED COMPLAINTS: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572535 CODMAN EXTERNAL DRAINAGE SYSTEM III SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention