BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT. DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 4130094 · Received September 30, 2014

    Report

    Report Number
    1226348-2014-12014
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 9, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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. COMPLAINT SAMPLE DISCARDED BY CUSTOMER

    Description of Event or Problem · 1

    THE CASING AT THE CSF PORT WAS CRACKED, SO A CSF LEAK WAS DISCOVERED UPON FLUSHING THE BLOCKED DRAIN. THE BUNG AT THE CSF PORT WAS REMOVABLE. PATIENT OUTCOME NOT KNOWN. NO REPORTED ADVERSE EVENT TO PATIENT. ON (B)(6) 2014, ADDITIONAL QUESTIONS ASKED TO CUSTOMER: WHAT DOES ¿THE BUNG AT THE CSF PORT WAS REMOVABLE¿ MEAN? THE NEEDLELESS CSF SAMPLE PORT WAS REMOVABLE (BY TWISTING WITH NORMAL PRESSURE) FROM THE HARD PLASTIC JOINT CASING WHERE THE WORD CSF IS WRITTEN (WHICH IS, RIGHT BY THE WORD CSF ON THE JOINT, ALSO THE LOCATION WHERE THE LEAK WAS IDENTIFIED). WHAT ACTIONS WERE TAKEN BY THE SURGEON? AS THE SYSTEM WAS BLOCKED AND NOT ABLE TO BE FLUSHED OPEN DURING USE, THE DECISION WAS MADE TO REPLACE IT WITH AN IDENTICAL UNIT. WAS THE SYSTEM REPLACED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608225 EXT. DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention