BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUDRAIN WITH ANTI-REFLUX VALVE

    MDR report key: 7211666 · Received January 23, 2018

    Report

    Report Number
    2648988-2018-00003
    Event Type
    Injury
    Date Received
    January 23, 2018
    Date of Event
    December 31, 2017
    Report Date
    December 31, 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 · 0

    SUS VOLUNTARY EVENT REPORT (FOI FOR MANUFACTURERS) MW5076332 RECEIVED ON 16APR2018.

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED ON 26JAN2018. THE ACTUAL DEVICE INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVALUATION. HOWEVER, (B)(4) UNOPENED UNITS AND ONE PIECE OF A PATIENT LINE WITH A STOPCOCK WERE RETURNED. THE (B)(4) WERE DISTRIBUTED AS FOLLOWS: DEVICE LOT NUMBER: 1165917 (QUANTITY (B)(4)); 1171342 (QUANTITY (B)(4)); 1170018 (QUANTITY (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. THE LOT OF THIS STOPCOCK COULD NOT BE ASSESSED SINCE IT WAS SEVERED FROM THE REST OF THE DEVICE. THE DOCUMENTATION REVIEW OF REPORTED LOT 1165917 AS WELL AS THE REPORTED LOTS OF THE UNOPENED UNITS DID NOT REVEAL ANY ANOMALIES THAT COULD CAUSE THE REPORTED CONDITION. NO EVENT, NCR AND/OR REWORK WAS RECORDED; THEREFORE, IT IS CONCLUDED THAT THE LOTS COMPLIED WITH ALL IN-PROCESS INSPECTIONS AND TESTING REQUIREMENTS AS SPECIFIED IN THE MANUFACTURING SHOP ORDER AND RELATED PROCEDURES. THE COMPLAINT IS UNCONFIRMED. THE ROOT CAUSE IS UNDETERMINED.

    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, 2648988-2017-00078 AND 2648988-2017-00079.

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2017 THAT AN XXX-ACCUDRAIN STOP COCK WAS CRACKED. THERE WAS A LEAK FROM SMALL TO MODERATE AMOUNT OF CEREBROSPINAL FLUID. THE BRAND OF TRANSDUCER USED WAS UNKNOWN. THE ACCUDRAIN WAS FIRST USED ON THE PATIENT ON (B)(6) 2017 AND REPLACED ON (B)(6) 2017 AND PATIENT'S ICP WAS TRANSDUCED USING SYSTEM REPLACEMENT.. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55991 ACCUDRAIN WITH ANTI-REFLUX VALVE N/A JXG INTEGRA NEUROSCIENCES PR 1165917

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R