BEUDAMED
    FDA Adverse Event Death Summary report: N

    10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE

    MDR report key: 7866933 · Received September 11, 2018

    Report

    Report Number
    1911916-2018-00531
    Event Type
    Death
    Date Received
    September 11, 2018
    Date of Event
    August 24, 2018
    Report Date
    September 5, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K141311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES WERE PROVIDED FOR EVALUATION. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF THIS BATCH # DURING THIS PRODUCTION RUN. ALL OUR INSPECTIONS PERFORMED WHILE MANUFACTURING THIS BATCH # WAS ACCEPTED; NO REJECTIONS WERE DOCUMENTED. CONTROLS IN PLACE AT THE MANUFACTURING SITE: BIOBURDEN TESTED ON A WEEKLY BASIS. AN OVERKILL STERILIZATION PROCESS IS USED. ENVIRONMENTAL TESTING WITHIN THE FILLING AREA IS DONE ON A BIWEEKLY BASIS. THE STERILIZATION PROCESS IS CHALLENGED AND RE-QUALIFIED ANNUALLY. THE SOLUTION IS FILTERED TWICE BEFORE IT IS FILLED IN SYRINGES (NOTE: ONCE WHEN TRANSFERRING TO THE HOLD TANK AND AGAIN AT THE FILL MACHINE). ENDOTOXIN TESTING IS PERFORMED ON EACH BATCH. FILL ROOM OPERATORS ARE TRAINED AND QUALIFIED ON GOWNING FOR THE FILL ROOM ENVIRONMENT ON AN ANNUAL BASIS. WEEKLY BIOBURDEN TESTING ON THE COMPONENTS USED TO ASSEMBLE THE SYRINGES. CONTINUOUS ONLINE MONITORING OF THE WFI (WATER FOR INJECTION) WATER QUALITY (NOTE: THIS IS FOR TOC (TOTAL ORGANIC CARBON) AND CONDUCTIVITY, NOT MICROBIAL. WEEKLY BIOBURDEN AND ENDOTOXIN TESTING OF THE USP (UNITED STATES PHARMACOPEIA) PURIFIED WATER AND WFI SYSTEMS. WEEKLY ENDOTOXIN TESTING OF THE PURE STEAM SYSTEM. EACH STERILIZER IS THOROUGHLY VALIDATED BEFORE USE FOR POSIFLUSH STERILIZATION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: THIS IS THE FIRST COMPLAINT FOR LOT # 8102908 FOR THIS TYPE OF DEFECT OR SYMPTOM. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH #8102908 DURING THIS PRODUCTION RUN. ROOT CAUSE DESCRIPTION: UNDETERMINED.

    Description of Event or Problem · 1

    A PATIENT'S SON REPORTED THAT HIS FATHER PASSED AWAY ON (B)(6) 2018. THE CAUSE OF DEATH WAS REPORTED AS A HEART ATTACK RELATED TO A BLOOD CLOT. THE PATIENT ALSO HAD A HISTORY OF SEPTIC SHOCK, (B)(6) FROM GANGRENE IN (B)(6), A PARTIAL FOOT AMPUTATION, A HEART ATTACK THREE MONTHS PRIOR TO HIS DEATH WITH ONE STENT PLACED IN HIS LEFT LEG AND TWO STENTS PLACED IN HIS HEART, AND WAS HOSPITALIZED FOR ONE MONTH. THE PATIENT'S SON INDICATED THAT THESE EVENTS OCCURRED WHILE THE PATIENT WAS USING A 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708416 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE PREFILLED SALINE FLUSH SYRINGE NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 8102908 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R