BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN LUMBER CATHETER KIT

    MDR report key: 15319972 · Received August 30, 2022

    Report

    Report Number
    3014334038-2022-00186
    Event Type
    Malfunction
    Date Received
    August 30, 2022
    Date of Event
    August 5, 2022
    Report Date
    October 20, 2022
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10886704040811
    PMA / PMN Number
    K964923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H4, H6, H10. THE CATHETER WAS RETURNED FOR EVALUATION: DHR - NO ANOMALIES OCCURRED DURING THE MANUFACTURING PROCESS. FAILURE ANALYSIS - PRODUCT WAS RETURNED TO THE ANALYSIS SITE FOR FAILURE ANALYSIS, AND THE FOLLOWING WAS PERFORMED ON THE RETURNED UNIT: THE ANALYSIS SITE PROVIDED PHOTOS OF THE RETURNED UNIT, IN WHICH YOU CAN VISUALIZE THAT THE CATHETER IS TORN WITH THE STYLET/GUIDEWIRE STILL INSERTED. THE COMPLAINT IS CONFIRMED. ROOT CAUSE - PER THE COMPLAINT BACKGROUND, CATHETER WAS TORN. THE COMPLAINT WAS CONFIRMED IN THE COMPLAINT INVESTIGATION. THE LIKELY ROOT CAUSE INCLUDES STYLET INTERFERENCE WITH CATHETER WALL.

    Description of Event or Problem · 0

    1 OF 2 REPORTS. (SAME PATIENT, SAME EVENT, DIFFERENT PRODUCTS) OTHER MFG REPORT NUMBER: 2648988-2022-00017. A FACILITY REPORTED A LUMBAR CATHETER KIT (ID 821707) WAS USED FOR LUMBAR DRAINAGE TO EVACUATE EXCESS CSF ON AN ADULT PATIENT. DURING EXTERNAL LUMBAR DERIVATION, AFTER USE OF TROCAR (INCLUDED INTO THE KIT), AND THE INTRODUCTION OF DERIVATION CATHETER WITH MANDREL, IT WAS IMPOSSIBLE TO REMOVE THE MANDREL, WHICH FINALLY TORE THE CATHETER. THE MEDICAL TEAM IS WONDERING IF THE ENTIRE CATHETER WAS COMPLETELY REMOVED (DID NOT LOSE SOME PARTS). HOWEVER, THE PATIENT WAS NOT INJURED, BUT THE DYSFUNCTION LED TO INCREASED SURGERY TIME (CUSTOMER DID NOT KNOW FOR HOW LONG). THE CUSTOMER IS UNAWARE OF HOW THE PATIENT IS DOING NOW.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315523 CODMAN LUMBER CATHETER KIT SHUNT, NERVOUS SYSTEM & COMPS JXG INTEGRA LIFESCIENCES MANSFIELD 82-1707 J67H20 10886704040811

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown