BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIAL EVD 10-110 W/O Y SITE

    MDR report key: 5942730 · Received September 12, 2016

    Report

    Report Number
    2648988-2016-00037
    Event Type
    Injury
    Date Received
    September 12, 2016
    Date of Event
    August 18, 2016
    Report Date
    August 24, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K920156
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON 19SEP2016 WITH THE FOLLOWING: THE TRANSDUCER OF THE VENTRICULOSTOMY FELL OFF WHILE PREPARING TO MOVE THE PATIENT TO THE STRETCHER FOR TRANSPORT. THE VENTRIC WAS REPLACED A WITH NEW SET UP. LOT NUMBER OF THE SP0090 WAS UNKNOWN. THE AMOUNT OF CSF LEAK WAS UNKNOWN. THE CUSTOMER RESPONDED NO PATIENT INJURY WHEN ASKED IF THERE WAS ANY OTHER ADVERSE EVENT IN ADDITION TO THE CSF LEAK . PATIENT OUTCOME WAS ALSO REPORTED AS NO INJURY.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 18OCT2016. THE INVESTIGATION ACTIVITIES INCLUDED: METHODS: -EVALUATION OF ACTUAL DEVICE. -REVIEW OF DEVICE HISTORY RECORDS. - REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. RESULTS: UPON RECEIPT OF UNIT, THE LOT NUMBER WAS FOUND ON THE DEVICE¿S LABEL. THE LOT NUMBER WAS 1162268. AFTER VERIFYING THAT THE LOT MET ALL ESTABLISHED REQUIREMENTS, THIS LOT WAS RELEASED ON 6/14/16. NOTHING UNUSUAL WAS NOTICED IN THE DHR REVIEW THAT COULD HAVE CAUSED THE REPORTED EVENT. UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM THERE IS NO OTHER COMPLAINT RELATED TO ¿CSF LEAKAGE DUE TO TRANSDUCER DISCONNECTION¿ FOR THE FOR EXTERNAL DRAINAGE (MONITOR) PRODUCT FAMILY. APPROXIMATELY (B)(4) UNITS WERE RELEASED FOR DISTRIBUTION FROM AUGUST 2014 TO AUGUST 2016. THE COMPLAINT OCCURRENCE RATE FOR THIS TYPE OF INCIDENT IS 0.003%. CONCLUSION: FAILURE ANALYSIS EVALUATION DEMONSTRATED THE FOLLOWING: ¿ THE TRANSDUCER IS NOT MANUFACTURED BY INTEGRA LIFESCIENCES. INTEGRA LIFESCIENCES MAKES NO CLAIMS REGARDING THE COMPATIBILITY (FIT OR PERFORMANCE) OF THIS PRODUCT (SP0090) WITH OTHER MANUFACTURERS¿ COMPONENTS (IN THIS CASE: THE TRANSDUCER). ¿ INTEGRA¿S DRAINAGE SYSTEM¿S STOPCOCKS WERE IN GOOD CONDITION (NOT CRACKED OR DEFORMED). ¿ WHEN THE TWO (2) COMPONENTS ARE TIGHTLY FASTENED, THERE IS A GOOD HOLD AND IT IS VERY UNLIKELY THAT A DISCONNECTION WOULD OCCUR WITHOUT AN EXTERNAL CAUSE. ¿ UNDER-TIGHTENING IS POSSIBLE AS RESISTANCE AND TIGHTENING ¿SQUEAK¿ NOISES ARE EXPERIENCED WHEN TURNING THE LUER-NUT WHICH MAY LEAD TO THINK THAT THE PROCESS HAS BEEN COMPLETED. ¿ INCORRECT TIGHTENING PROCEDURE (TURNING THE TRANSDUCER INSTEAD OF THE MALE LUER NUT) COULD LEAD TO A WEAK CONNECTION (UNDER-TIGHTENED LUER-NUT). ¿ LOOSENING OF THE CONNECTION IS POSSIBLE IF THE TRANSDUCER IS INADVERTENTLY ROTATED ON ITS OWN AXIS. THIS IS VERY PROBABLE (ESPECIALLY IF UNDER-TIGHTENED) SINCE THE PATIENT WAS BEING PREPARED TO BE MOVED TO A STRETCHER FOR TRANSPORT. IT DOESN¿T TAKE MUCH CONSIDERING THAT IT ONLY TAKES ABOUT HALF A TURN (OR 1/3 DEPENDING ON METHOD USED) TO TIGHTEN THE COMPONENTS. NO DEFECTS WERE FOUND ON THE EXTERNAL DRAINAGE SYSTEM, CATALOG NUMBER - SP0090. THE IFU MAKES THE FOLLOWING STATEMENT: ¿INTEGRA NEUROSCIENCES MAKES NO CLAIM FOR OR REPRESENTATION AS TO THE PERFORMANCE CHARACTERISTICS OF THIS PRODUCT IF IT IS USED IN CONJUNCTION WITH COMPONENTS OF OTHER MANUFACTURERS.¿

    Description of Event or Problem · 1

    THE PRODUCT WAS CONNECTED TO THE PATIENT IN THE INTENSIVE CARE UNIT (ICU) AND THE FLUID TRANSFUSER WAS DISCONNECTED WHICH CAUSED CEREBROSPINAL FLUID (CSF) TO LEAK. REVISION/MEDICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595198 SPECIAL EVD 10-110 W/O Y SITE N/A JXG INTEGRA NEUROSCIENCES PR 1162268

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention