BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE

    MDR report key: 6683903 · Received July 3, 2017

    Report

    Report Number
    2648988-2017-00020
    Event Type
    Injury
    Date Received
    July 3, 2017
    Date of Event
    April 20, 2017
    Report Date
    June 13, 2017
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    PMA / PMN Number
    K042825
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 7/13/2017. DEVICE HISTORY RECORD (DHR) OF LOT NUMBER 1164444 WAS REVIEWED. LOT NUMBER: 1164444, CATALOG NUMBER: INS-8400, DEVICE IDENTIFIER: (B)(4), PRODUCT IDENTIFIER: (17)180831(10)1164444, MANUFACTURING (PACKAGING) DATE: SEPTEMBER 23, 2016, EXPIRATION DATE: AUGUST 31, 2018. THE MANUFACTURING AND FINAL PACK PROCESSES RAN NORMALLY; NO ANOMALIES WERE FOUND DURING MANUFACTURING PROCESS OF THE PRODUCT. THIS LOT WAS RELEASED ON OCTOBER 15, 2016. THE RETURNED SAMPLE LOT NUMBER WAS DIFFERENT TO THE ONE REPORTED IN THE MEDWATCH. THE RETURNED UNIT¿S LOT NUMBER WAS 1163007; THEREFORE, DHR REVIEW FOR LOT 1163007 WAS PERFORMED ALSO. THE MANUFACTURING AND FINAL PACK PROCESSES RAN NORMALLY; NO ANOMALIES WERE FOUND DURING MANUFACTURING PROCESS OF THE PRODUCT. THIS LOT WAS RELEASED ON JULY 27, 2016. REVIEW OF PRODUCT'S NCR, AND CAPA HISTORY FROM JUNE 2015 ¿ JUNE 2017: NO RELATED NCR OR CAPA WAS FOUND TO HAVE BEEN OPENED DURING THE PERIOD OF JUNE 2015 TO JUNE 2017. UPON REVIEW OF INTEGRA'S COMPLAINT SYSTEM FROM JUNE 2015 TO JUNE 2017, THERE ARE THREE (3) COMPLAINTS RELATED TO ¿CONNECTING PIECE FROM BURETROL TO DRAINAGE SYSTEM BROKE OFF¿ INCLUDING THIS ONE. THESE LOT NUMBERS (1164444/1163007) HAVE NOT BEEN REPORTED IN ANY OTHER BURETTE STOPCOCK BREAKING-OFF COMPLAINT. APPROXIMATELY 80,874 UNITS OF ACCUDRAIN EXTERNAL DRAINAGE PRODUCT FAMILIES AND ACCESSORIES WERE RELEASED FOR DISTRIBUTION FROM JUNE 2015 TO JUNE 2017. THE COMPLAINT OCCURRENCE RATE FOR THIS TYPE OF INCIDENT IS THEN 0.004%. ONE DEVICE WAS RECEIVED WHICH WAS OF A DIFFERENT LOT NUMBER (1163007) THAN THE ONE REPORTED IN THE COMPLAINT (1164444). THE DEVICE WAS NOT IN ITS ORIGINAL PACKAGE; THUS, CONDITION OF EXTERNAL PACKAGE (E.G., DISPENSER BOX) COULD NOT BE EVALUATED FOR EVIDENCE OF SHIPPING/HANDLING DAMAGE. THE DEVICE WAS EVIDENTLY USED SINCE A TRANSDUCER WAS ATTACHED TO THE PATIENT LINE¿S STOPCOCK. THE DEVICE WAS INSPECTED AND IT WAS OBSERVED THAT THE LARGE BORE STOPCOCK AT THE BOTTOM OF THE BURETTE WAS COMPLETELY BROKEN-OFF. IT WAS ALSO NOTICED SOME GREEN MARKS ON THE LOWER PART OF THE PANEL AND DRAIN BAG HOLDER (LEFT-HAND SIDE OF THE STOPCOCK/DRAIN BAG AREA) AS IF IT WAS SCUFFED AGAINST SOME SURFACE. THE GREEN MARKS WERE NOT SEEN ELSEWHERE ON THE DEVICE. NO UNUSUAL EVENT RELATED TO THE REPORTED FAILURE WAS NOTICED DURING THE RECORDS REVIEW OF THIS LOT AND NO OTHER COMPLAINT RELATED TO THIS CONDITION HAVE BEEN RECEIVED FOR EITHER OF THE TWO (2) FINISHED GOOD LOT NUMBERS MENTIONED IN THIS INVESTIGATION. IN CONCLUSION, THERE ARE PROCEDURAL CONTROLS IN PLACE TO DETECT AND PREVENT THIS KIND OF DEFECT. THE WAY THIS STOPCOCK IS BROKEN (SNAPPED IN TWO), IT WOULD BE NEARLY IMPOSSIBLE TO MISS DURING ASSEMBLY, INSPECTIONS, AND TESTS PERFORMED DURING MANUFACTURING OPERATIONS. IT IS UNKNOWN THE CIRCUMSTANCES SURROUNDING THE BREAKAGE (MOVING THE PATIENT, CHANGING THE DRAINAGE BAG, ETC.) TO FULLY UNDERSTAND HOW WAS THE DEVICE BROKEN. THE EVIDENCE LEADS TO CONCLUDE THAT THE STOPCOCK/BURETTE CONNECTION MOST LIKELY BROKE AT THE FIELD OUTSIDE INTEGRA¿S CONTROL; THUS, THE MOST PROBABLE CAUSE FOR THE BREAKAGE IS AN INADVERTENT BLOW (MAYBE BUMPED AGAINST A HARD SURFACE) OR EXCESSIVE FORCE APPLIED OVER THE STOPCOCK.

    Description of Event or Problem · 1

    RN NOTED CONNECTING PIECE FROM BURETROL TO DRAINAGE SYSTEM BROKE OFF. CEREBROSPINAL FLUID (CSF) LEAKING FROM BURETROL CONNECTION TO DRAINAGE BAG. THE EXTERNAL VENTRICULAR DRAINAGE (EVD) SYSTEM WAS CLAMPED AND THE TEAM WAS NOTIFIED AS WELL. NEW EVD SYSTEM WAS FLUSHED AND PREPARED FOR TEAM TO REPLACE. THE PATIENT'S NEURO STATUS REMAINS UNCHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464763 ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE N/A JXG INTEGRA NEUROSCIENCES PR 1164444

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other