BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN LUMBER CATHETER KIT

    MDR report key: 15065723 · Received July 20, 2022

    Report

    Report Number
    3014334038-2022-00159
    Event Type
    Malfunction
    Date Received
    July 20, 2022
    Report Date
    October 19, 2022
    Manufacturer
    RAYNHAM
    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 CODMAN LUMBER CATHETER WAS NOT RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) REVIEW - THE BATCH RECORD WAS REVIEWED FOR ANY ANOMALIES OR NCS RELATED TO THE FINISHED LOT (J57G69), AND IT IS NOTED THAT NO ANOMALIES OCCURRED DURING THE MANUFACTURING PROCESS. FAILURE ANALYSIS - PRODUCT WAS NOT RETURNED TO THE ANALYSIS SITE FOR FAILURE ANALYSIS DUE TO SHIPPING/LOGISTICS DIFFICULTIES, HOWEVER PHOTOS WERE PROVIDED OF THE PRODUCT FOR ANALYSIS, AND THE FOLLOWING WAS PERFORMED ON THE PROVIDED PHOTOS: IN THE PHOTOS PROVIDED, THERE IS VISIBLE DAMAGE TO ONE END OF THE CATHETER, CONFIRMING THE CUSTOMER¿S COMPLAINT OF THE PRODUCT ¿SHREDDING¿ APART. THE COMPLAINT WAS CONFIRMED IN THE COMPLAINT INVESTIGATION. THE POSSIBLE ROOT CAUSES INCLUDE INADEQUATE TIP TO CATHETER BOND STRENGTH OR INCORRECT SURGICAL TECHNIQUE.

    Description of Event or Problem · 0

    A FACILITY REPORTED A LUMBAR CATHETER (ID 821707) WAS USED ON A LUMBAR INSERTION AND THE TIP OF THE CATHETER SHREDDED APART ONCE IT WAS INSERTED INTO THE PATIENT. ALL VISIBLE PARTS WERE RECOVERED. NO PATIENT INJURY REPORTED. SURGICAL DELAY WAS REPORTED; HOWEVER, IT IS UNKNOWN FOR HOW LONG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648408 CODMAN LUMBER CATHETER KIT SHUNT, NERVOUS SYSTEM & COMPS JXG RAYNHAM 82-1707 J57G69 10886704040811

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown