BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSARIA

    MDR report key: 10385371 · Received August 10, 2020

    Report

    Report Number
    2916837-2020-00078
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 20, 2020
    Report Date
    September 22, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ¿ PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT ON A FACSARIA SPECIAL ORDER SYSTEM ETO ¿ 650110 OF AN INTERMITTENT WASTE LEAKAGE, WITHOUT BLEACH, NOT CONTAINED WITHIN THE INSTRUMENT. ¿ MANUFACTURING DEFECT TREND: THERE ARE ZERO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 20JUL2019 TO DATE 20JUL2020. ¿ COMPLAINT TREND: THIS IS THE ONLY COMPLAINT, RELATED TO THIS ISSUE OF INTERMITTENT WASTE LEAKAGE, WITHOUT BLEACH, NOT CONTAINED WITHIN THE INSTRUMENT. DATE RANGE FROM 20JUL2019 TO DATE 20JUL2020. ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF DHR PART # 650110 SERIAL # (B)(6). FILE # (B)(4), WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ¿ INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, AND RISK ANALYSIS, THE ROOT CAUSE OF THE INTERMITTENT WASTE LEAKAGE, WITHOUT BLEACH, NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A FAULTY WASTE CONNECTOR, 59-10092-05 CPLN BDY PANL MT 1/8 JD ORG. THE FSE (FIELD SERVICE ENGINEER) CONFIRMED THE ISSUE AND REPLACED THE PART. ALTHOUGH THE LEAK WAS ON THE OUTSIDE PANEL OF THE WETCART AND WAS NOT CONTAINED WITHIN THE INSTRUMENT, NO USER WAS IN CONTACT WITH BIOHAZARD WASTE NOR WAS THERE INJURY BECAUSE THEY WERE WEARING PROPER PPE (PERSONAL PROTECTIVE EQUIPMENT). AFTER THE REPAIR, THE INSTRUMENT WAS REBOOTED, TESTED AND FUNCTIONING AS EXPECTED. THE SAFETY RISK IS LOW BECAUSE THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: 01538408, CASE # 01090321 INSTALL DATE: 30JUL2012 DEFECTIVE PART NUMBER: 59-10092-05 CPLN BDY PANL MT 1/8 JD ORG WORK ORDER NOTES: O SUBJECT / REPORTED: SHEATH PRESSURE TOO LOW AT 60PSI O PROBLEM DESCRIPTION: - PROBLEM 1 CALLER SAYS THAT THEY CANNOT COMPLETE THEIR FLUIDIC STARTUP OR SHUTDOWN. THERE DOESN'T SEEM TO BE ANY FLUIDIC MOVEMENT NOW - PROBLEM 2 LEAK UNDER WET CART O WORK PERFORMED: - PROBLEM 1 COULD NOT DUPLICATE. COMPLETED FLUIDIC STARTUP AND SHUTDOWN TWICE WITH NO PROBLEM. PRESSURE STABLE AT 100 PSI. - PROBLEM 2 FOUND THAT ONE OF THE CONNECTORS COMING INTO THE WET CART WAS LEAKING. LEAK WAS NO CONTAINED WITHIN INSTRUMENT. LEAK WAS WASTE BEFORE BLEACHED WASTE CONTAINER. THE SOURCE WAS 1/8 FEMALE QUICK CONNECTOR - WASTE LINE. THE CUSTOMER WAS NOT EXPOSED TO BODILY FLUIDS. THE CUSTOMER WAS NOT PHYSICALLY HARM AS A RESULT OF THE LEAK. QUICK CONNECTOR 59-10092-05 REPLACED WITH CUSTOMER STOCK ITEM. LEAK CORRECTED. COMPLETED CS&T ON BOTH THE 70 AND 100 NOZZLE. CUSTOMER UNAVAILABLE FOR SIGNATURE. O CAUSE: - PROBLEM 1 COULD NOT DUPLICATE - PROBLEM 2 FAULTY CONNECTOR O SOLUTION: - PROBLEM 1 COULD NOT DUPLICATE - PROBLEM 2 REPLACING THE CONNECTOR CORRECT ORIGINAL PROBLEM. THE INSTRUMENT IS TESTING WITHOUT ERRORS AND I HAVE RETURNED THE INSTRUMENT TO THE LAB FOR NORMAL USE. ¿ RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE IT IS NOT A RETURNABLE PART AND WAS DISCARDED. ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART #100286RA, VERSION G, FACSARIA FUSION RISK ANALYSIS WAS REVIEWED. NO NEW HAZARD HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATIONS ARE SUFFICIENT. HAZARD(S) IDENTIFIED? ¿YES ¿NO O ID: 2.1.1 O HAZARD: UNCONTROLLED RELEASE OF BIOHAZARDOUS FLUIDS O CAUSE: WASTE PATHWAY COMPONENT INSTALLATION ISSUE AND/OR FAILURE O HARMFUL EFFECTS: EXPOSURE TO ENVIRONMENT OR USER O RISK CONTROLS: DESIGN REVIEW O IMPLEMENTATION VERIFICATION: REASSESS RISK AFTER DESIGN REVIEW O EFFECTIVENESS VERIFICATION: - CONTAMINATION CONTAINED WITHIN SYSTEM - COLLECTION TRAY - CLEAN UP KIT O PROPABILTIY: 1 O SEVERITY: 2 O RISK INDEX: 2 O RESIDUAL RISK EVALUATION: A O NEW HAZARDS: NONE MITIGATION(S) SUFFICIENT ¿YES ¿NO ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE WAS DUE TO A FAULTY WASTE CONNECTOR, 59-10092-05 CPLN BDY PANL MT 1/8 JD ORG. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE OF THE INTERMITTENT WASTE LEAKAGE, WITHOUT BLEACH, NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A FAULTY WASTE CONNECTOR, 59-10092-05 CPLN BDY PANL MT 1/8 JD ORG. THE FSE HAD CONFIRMED THE ISSUE AND PERFORMED THE REPAIR. THE INSTRUMENT WAS REBOOTED, TESTED AND FUNCTIONING AS EXPECTED. THE SAFETY RISK IS LOW BECAUSE THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT WITH A BD FACSARIA¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2COMPLAINTS) IT WAS REPORTED THAT THERE WAS A LEAK UNDER THE WET CART. ADDITIONALLY, ON 2020-7-20 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: FOUND THAT ONE OF THE CONNECTORS COMING INTO THE WET CART WAS LEAKING. LEAK WAS NO CONTAINED WITHIN INSTRUMENT. LEAK WAS WASTE BEFORE BLEACHED WASTE CONTAINER. THE SOURCE WAS 1/8 FEMALE QUICK CONNECTOR - WASTE LINE. THE CUSTOMER WAS NOT EXPOSED TO BODILY FLUIDS. THE CUSTOMER WAS NOT PHYSICALLY HARM AS A RESULT OF THE LEAK. QUICK CONNECTOR 59-10092-05 REPLACED WITH CUSTOMER STOCK ITEM. LEAK CORRECTED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT WITH A BD FACSARIA¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2 COMPLAINTS) IT WAS REPORTED THAT THERE WAS A LEAK UNDER THE WET CART. ADDITIONALLY, ON 2020-7-20 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: FOUND THAT ONE OF THE CONNECTORS COMING INTO THE WET CART WAS LEAKING. LEAK WAS NO CONTAINED WITHIN INSTRUMENT. LEAK WAS WASTE BEFORE BLEACHED WASTE CONTAINER. THE SOURCE WAS 1/8 FEMALE QUICK CONNECTOR - WASTE LINE. THE CUSTOMER WAS NOT EXPOSED TO BODILY FLUIDS. THE CUSTOMER WAS NOT PHYSICALLY HARM AS A RESULT OF THE LEAK. QUICK CONNECTOR 59-10092-05 REPLACED WITH CUSTOMER STOCK ITEM. LEAK CORRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853289 BD FACSARIA NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other