BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN LUMBER CATHETER KIT

    MDR report key: 10731265 · Received October 23, 2020

    Report

    Report Number
    3014334038-2020-00077
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Report Date
    October 7, 2020
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K964923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CATHETER WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE CUSTOMER; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ANOMALIES. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. THE COMPLAINT WAS CONFIRMED IN THE COMPLAINT INVESTIGATION BASED OFF THE PICTURES SUPPLIED. THE FMEA WAS REVIEWED FOR POTENTIAL ROOT CAUSES, AND THE LIKELY ROOT CAUSE IS WRONG MATERIAL OR WALL THICKNESS.

    Description of Event or Problem · 1

    2 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3014334038-2020-00076. A FACILITY REPORTED A BROKEN LUMBAR CATHETER. A LUMBAR DRAIN WAS INSERTED IN THE EMERGENCY DEPARTMENT. THE LUMBAR CATHETER KIT WAS USED, REF#: 82-1707; LOT #: J57G71, AND WAS FLUSHED WITH SALINE TO LOOSEN THE STYLET AND CATHETER. THERE WAS SMOOTH INSERTION OF LUMBAR NEEDLE, BUT DURING THE INSERTION OF THE CATHETER THERE WAS SOME RESISTANCE AND WHEN IT WAS PULLED OUT TO CHECK THE TIP, IT WAS BROKEN. THE BROKEN CATHETER WAS LEFT IN THE PATIENT. NO PATIENT INJURY WAS REPORTED. THEY USED ANOTHER DRAIN TO FINISH THE SURGERY. THERE WAS A 30-MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190066 CODMAN LUMBER CATHETER KIT SHUNT, NERVOUS SYSTEM & COMPS JXG INTEGRA LIFESCIENCES MANSFIELD J57G71

    Patients

    Seq Age Sex Outcome Treatment
    1