BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HERMETIC LUMBAR CATHETER, CLOSED TIP

    MDR report key: 5392732 · Received January 27, 2016

    Report

    Report Number
    2648988-2016-00005
    Event Type
    Injury
    Date Received
    January 27, 2016
    Date of Event
    February 8, 2015
    Report Date
    January 4, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K970658
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 12FEB2016: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER PROVIDED (114922) DOES NOT CORRESPOND TO AN ACTUAL INTEGRA LOT. THE CLOSEST LOT NUMBER FOUND FOR CATALOG NUMBER INS-5010 WAS 1141922. DHR FOR LOT 1141922 WAS REVIEWED. NO UNUSUAL EVENT WAS NOTICED DURING DOCUMENT REVIEW. HAVING COMPLIED WITH ALL REQUIREMENTS, THE LOT WAS RELEASED BY QA ON 7/15/2014. NO OTHER COMPLAINT WAS FOUND TO HAVE THE LUMBAR DRAIN DISCONNECTED FROM PATIENT'S BACK. THE CONDITION ¿LUMBAR DRAIN DISCONNECTED FROM PATIENT'S BACK¿ COULD NOT BE CONFIRMED GIVEN THAT NO COMPLAINT UNIT WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE NURSE RETURNED TO THE PATIENT'S ROOM WITH IV FLUID AND FOUND THE LUMBAR DRAIN DISCONNECTED FROM THE PATIENT'S BACK. THE PATIENT'S GOWN WAS DAMP. FORCEPS APPLIED TO THE PATIENT'S DRAIN SITE. ADDITIONAL INFORMATION RECEIVED ON 18JAN2016 FROM THE CUSTOMER WITH THE FOLLOWING: THE REASON FOR THE PLACEMENT OF THE LUMBAR CATHETER ON (B)(6) 2015 WAS UNKNOWN. NO INFORMATION WAS PROVIDED ON HOW THE CATHETER WAS SECURED TO THE PATIENT. THE PATIENT'S GOWN WAS DAMP; THIS WAS CEREBROSPINAL FLUID. THE EXACT AMOUNT OF CSF LEAKAGE WAS UNKNOWN BUT IT WAS REPORTED TO BE LARGE. AFTER THE FORCEPS WERE APPLIED TO THE DRAIN SITE, THE CATHETER WAS RECONNECTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL APPROXIMATELY TWO AND A HALF WEEKS LATER. LINKED TO MEDWATCH REPORT# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50846 HERMETIC LUMBAR CATHETER, CLOSED TIP N/A JXG INTEGRA NEUROSCIENCES PR 114922

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other