BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INS8400 WITH ONE FOOT OF PROXIMAL PATIENT LINE

    MDR report key: 6853718 · Received September 8, 2017

    Report

    Report Number
    2648988-2017-00032
    Event Type
    Injury
    Date Received
    September 8, 2017
    Date of Event
    August 22, 2017
    Report Date
    August 22, 2017
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K042825
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 05SEP2017 AND 14SEP2017: IT WAS REPORTED THAT ON (B)(6) 2017, THE (B)(6) PATIENT, WHO HAD A VENTRICULOSTOMY IN PLACE, WAS COMPLIANT AND IN THE ANGIO SUITE. AT NO TIME DID THE PATIENT MOVE IN SUCH A WAY AS TO TUG ON THE DRAIN. THE NURSE WENT DOWN TO PICK UP THE PATIENT POST PROCEDURE AND IT WAS NOTED THAT THE PILLOW WAS WET. IT WAS UNKNOWN HOW MUCH CSF LEAKED. ON FURTHER INSPECTION, IT WAS NOTED THAT THE STOPCOCK MOST PROXIMAL TO THE PATIENT HAD COME COMPLETELY OUT OF PLACE AND SPINAL FLUID WAS DIPPING OUT. THERE WERE NO SIGNS OF TRAUMA TO THE TUBING AND CRACKS NOTED. THE WHITE STOPCOCK WAS MISSING COMPLETELY. IT WAS UNKNOWN HOW LONG THE DEVICE WAS NOT CONNECTED AND EXPOSED TO AIR. NEUROSURGERY WAS NOTIFIED. A NEW DRAIN WAS PLACED. THE ATTENDING WAS NOTIFIED AND WANTED THE DRAIN REMOVED IMMEDIATELY. THE PATIENT WAS THEN STARTED ON TRIPLE ANTIBIOTICS. THE CUSTOMER STATED THAT THEY HAVE NOT HEARD OF ANY OTHER ADVERSE OUTCOME. THE LOT NUMBER OF THE DEVICE WAS UNKNOWN. LINKED TO UF/ IMPORTER REPORT # (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 11/17/2017. COMPLAINT INFORMATION DID NOT IDENTIFY A LOT NUMBER, BUT LOT NUMBER 1170024 WAS OBTAINED FROM THE RETURNED UNIT¿S LABEL. NO MANUFACTURING EVENT OR REWORK WAS IDENTIFIED RELATED TO THIS LOT. MANUFACTURING (PACK) DATE: JANUARY 19, 2017. EXPIRATION DATE: DECEMBER 31, 2018. REVIEW OF COMPLAINT SYSTEM FROM (B)(6) 2015 TO (B)(6) 2015 FOUND THAT THERE ARE NO PREVIOUS CASES IN THE TWO (2) YEAR PERIOD REVIEWED IN WHICH THE STOPCOCK¿S PLUG HAD FALLEN OFF. THE COMPLAINT OCCURRENCE RATE FOR THIS TYPE OF INCIDENT IS THEN (B)(4). RETURNED UNIT HAD ALL THE DEVICE¿S COMPONENTS EXCEPT THE WHITE PLUG FROM THE PATIENT LINE¿S STOPCOCK. A TRANSDUCER WAS FOUND STILL ATTACHED TO THE ZERO-REFERENCE STOPCOCK. THE ZERO-REFERENCE STOPCOCK WAS ALSO INSPECTED SINCE IT IS THE SAME PART NUMBER (200407-001) AS THE ONE USED IN THE PATIENT LINE. NO DEFECTS WERE OBSERVED IN THE ZERO-REFERENCE STOPCOCK. THE PATIENT LINE STOPCOCK WAS INSPECTED AND BESIDES MISSING THE WHITE PLUG, THERE WAS NO OTHER DEFECT DETECTED (I.E., CRACKS OR OBSERVABLE DEFORMITY). NO EVIDENCE OF MANUFACTURING ERROR WAS FOUND THAT COULD HAVE CAUSED THE REPORTED CONDITION. THERE ARE CONTROLS IN PLACE TO DETECT COMPONENTS FAILURE. THE ROOT CAUSE COULD BE RELATED TO PRODUCT HANDLING, BUT CANNOT BE CONFIRMED; THEREFORE, THE ROOT CAUSE FOR THIS EVENT IS CONSIDERED UNKNOWN.

    Description of Event or Problem · 1

    THE STOPCOCK AT THE PROXIMAL END OF THE TUBING CLOSEST TO THE PATIENT WAS EITHER PULLED OUT OR FELL OUT. CEREBROSPINAL FLUID (CSF) LEAKED OUT ONTO THE PILLOW AND AIR WAS INTRODUCED INTO THE BRAIN. IT WAS REPORTED THAT THE PATIENT WILL MOST LIKELY REQUIRE A SHUNT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633757 INS8400 WITH ONE FOOT OF PROXIMAL PATIENT LINE N/A JXG INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other