BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUDRAIN WITH ANTI-REFLUX VALVE

    MDR report key: 7165238 · Received January 4, 2018

    Report

    Report Number
    2648988-2017-00079
    Event Type
    Injury
    Date Received
    January 4, 2018
    Date of Event
    December 3, 2017
    Report Date
    December 11, 2017
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K042825
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG. REPORT NUMBERS: 2648988-2017-00077 AND 2648988-2017-00078.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 04JAN2018 WITH THE FOLLOWING: THE ACCUDRAIN WAS FIRST USED ON THE PATIENT ON (B)(6) 2017. CEREBROSPINAL FLUID LEAK WAS QUANTIFIED FROM SMALL TO MODERATE AMOUNT. THE TYPE/BRAND OF TRANSDUCER USED WITH THE ACCUDRAIN WAS UNKNOWN. THE ACCUDRAIN WAS REPLACED ON (B)(6) 2017 AND THE PATIENT'S ICP WAS TRANSDUCED BY THE SYSTEM REPLACEMENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED ON 08FEB2018. ELEVEN (11) UNOPENED UNITS AND ONE PIECE OF A PATIENT LINE WITH A STOPCOCK WERE RETURNED. (B)(4). ALL (B)(4) UNITS WERE OPENED AND EACH UNIT¿S PATIENT LINE STOPCOCK WAS INSPECTED UNDER AN ILLUMINATED MAGNIFIER. THE STOPCOCKS¿ PLUG WAS FULLY ROTATED, SEVERAL TIMES, TO SIMULATE NORMAL USE. ALL STOPCOCKS OPERATED AS EXPECTED: NO CRACKS WERE OBSERVED. THE LOOSE PIECE SENT HAD TWO (2) CRACKS ON THE MAIN BODY OF THE STOPCOCK. SINCE IT IS ONLY A PIECE OF A DEVICE, THE LOT NUMBER CANNOT BE CONFIRMED. THE DOCUMENTATION REVIEW OF REPORTED LOT 1170018 AND THE LOTS OF THE UNOPENED UNITS DID NOT REVEAL ANY ANOMALIES THAT COULD CAUSE THE REPORTED CONDITION. NO EVENT, NCR AND/OR REWORK WAS RECORDED FOR THE MENTIONED LOTS; THEREFORE, IT IS CONCLUDED THAT THE LOT COMPLIED WITH ALL IN-PROCESS INSPECTIONS AND TESTING REQUIREMENTS AS SPECIFIED IN THE MANUFACTURING SHOP ORDER AND RELATED PROCEDURES. SINCE ONLY ONE PARTIAL UNIT WAS SENT, ONLY ONE OF THE COMPLAINTS WILL BE CONSIDERED CONFIRMED (MFG. REPORT NUMBER: 2648988-2017-00077). EACH DEVICE HAS TWO (2) OF THESE STOPCOCKS (SAME PART NUMBER): ONE AT PATIENT LINE AND ONE ON THE ZERO-REFERENCE POINT. ONLY THE PATIENT LINE STOPCOCK HAS BEEN REPORTED AS BROKEN. NO COMMON LOT OF STOPCOCKS WAS USED IN ANY OF THE REPORTED LOTS. THERE ARE CONTROLS TO AVOID THIS TYPE OF SITUATIONS. PRIOR TO USE, THE PATIENT LINE STOPCOCK IS VERIFIED 100% FOR CRACKS AND STRESS MARKS UNDER A MICROSCOPE 3X. ALSO, AFTER ASSEMBLY, EACH UNIT IS SUBMITTED TO LEAK AND OCCLUSION TESTING. THIS COMPLAINT IS UNCONFIRMED. THE ROOT CAUSE IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION IN THE FORM OF A MEDWATCH (MW5075575) WAS RECEIVED ON 19MAR2018 WITH THE FOLLOWING: ON (B)(6) 2017, THE DEVICE HAD A CRACK TO THE PROXIMAL PORT AND WAS BROKEN AT THE STOPCOCK. THERE IS NO CHANGE IN THE INVESTIGATION FINDINGS AND ROOT CAUSE PREVIOUSLY REPORTED BASED ON THE ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 1

    THIS IS THE THIRD OF THREE REPORTS. IT WAS REPORTED THAT AN INS8401 ACCUDRAIN HAVE BROKEN IN THE EXACT SAME POSITION AND FOUND TO BE "LEAKING CSF ONTO THE BED". THE NURSE SAID THEY WERE UNABLE TO TRANSDUCE INTRACRANIAL PRESSURE (ICP) AT WHICH POINT AIR WAS FOUND IN THE LINE AND CSF LEAKING FROM A CRACK IN THE DISTAL COLLECTION SYSTEM. REVISION AND/OR MEDICAL INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7507 ACCUDRAIN WITH ANTI-REFLUX VALVE N/A JXG INTEGRA NEUROSCIENCES PR 1170018

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R