BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN LUMBAR CATHETER KIT

    MDR report key: 4220716 · Received November 3, 2014

    Report

    Report Number
    1226348-2014-12074
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 20, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK964923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT DURING THE INVESTIGATION THE FOLLOWING OBSERVATIONS WERE FOUND: 1 - THE GUIDE WIRE WAS RECEIVED AND INSERTED IN THE CATHETER. 2 - CATHETER WAS DAMAGED BETWEEN 4" AND 5 1/4" FROM THE TIP. 3 - MISSING CATHETER MATERIAL AT THE DAMAGED AREA. 4 - NO OTHER DAMAGES OBSERVED. THE CAUSE(S) OF THE DAMAGE/MISSING CATHETER MATERIAL COULD NOT BE FULLY DETERMINED; HOWEVER, IT MIGHT BE POSSIBLE THAT THE DEVICE MAY HAVE BEEN DAMAGED DURING USE. THIS HOWEVER COULD NOT BE CONFIRMED. A LOT HISTORY RECORDS REVIEW FOR P/N 82-1707; LOT # 553541 WAS CONDUCTED AND IT WAS VERIFIED THAT ALL PRODUCTS IN THIS LOT NUMBER WERE CONFORMING TO THE REQUIRED SPECIFICATIONS WHEN RELEASED TO STOCK ON AUGUST 18, 2014. A COMPLAINTS RECORDS REVIEW WAS ALSO CONDUCTED, AND IT WAS VERIFIED THAT AT THE PRESENT DATE THIS IS THE FIRST COMPLAINT REPORTED FOR THIS LOT NUMBER, FOR THIS TYPE OF ISSUE, AND IT IS CONSIDERED TO BE AN ISOLATED INCIDENT. THE CAUSE(S) OF THE DAMAGE/MISSING CATHETER MATERIAL COULD NOT BE FULLY DETERMINED; HOWEVER, IT APPEARS TO HAVE BEEN INADVERTENTLY DAMAGE BY THE CUSTOMER DURING USE.

    Description of Event or Problem · 1

    AFFILIATE REPORTED (B)(4). THE CATHETER DIDN'T PROCEED INTO THE INTRODUCER NEEDLE BECAUSE IT WAS TORN FOR ABOUT 5-6CM. THE CATHETER WAS REMOVED AS SOON AS THE SURGEON NOTED THE DEFECT. NO PATIENT ADVERSE CONSEQUENCES HAVE BEEN REPORTED. REPOSITORY NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701777 CODMAN LUMBAR CATHETER KIT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC 553541

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR