BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT ENDO VENT CATH

    MDR report key: 4427178 · Received January 16, 2015

    Report

    Report Number
    1226348-2015-10039
    Event Type
    Malfunction
    Date Received
    January 16, 2015
    Date of Event
    January 7, 2015
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK003322
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT A BACTISEAL ENDO VENTRICULAR CATHETER P/N 82-3087, WITH AN UNKNOWN LOT NUMBER, WAS RETURNED TO CODMAN FOR EVALUATION. AS RECEIVED, IT WAS EVALUATED AND VERIFIED THAT THE RETURNED VENTRICULAR CATHETER HAD THE SLIT AT THE DISTAL END. THE SLIT WAS OPENED AFTER USING THE RECOMMENDATION IN THE IFU "GENTLY ROLL THE VENTRICULAR END OF THE CATHETER BETWEEN YOUR THUMB AND INDEX FINGER TO 'POP' THE SLIT IN THE TIP OPEN". NO LOT NUMBER WAS PROVIDED; THEREFORE A LOT HISTORY RECORDS REVIEW COULD NOT BE CONDUCTED. THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. NO ROOT CAUSE COULD BE DETERMINED AS NO PROBLEM WAS IDENTIFIED 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.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    REP REPORTED THAT WHEN THE SURGEON ATTEMPTED TO USE THE CATHETER HE COULD NOT FIND THE SLIT. THE REP WAS INFORMED OF THE PROCESS OF ROLLING THE CATHETER WITH THE FINGER TIPS TO EXPOSE THE TIP. HE WILL CONDUCT RETRAINING WITH THE CLINICIAN. THE DEVICE WAS NOT USED. THE CLINICIAN PULLED ANOTHER DEVICE. THERE WAS NO DELAY GREAT THAN 30 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39371 BACT ENDO VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF

    Patients

    Seq Age Sex Outcome Treatment
    1