BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC

    MDR report key: 11614502 · Received April 5, 2021

    Report

    Report Number
    2916837-2021-00145
    Event Type
    Malfunction
    Date Received
    April 5, 2021
    Date of Event
    February 22, 2021
    Report Date
    September 8, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO FACSLYRIC 3L10C INSTRUMENT, PART # 659180, SERIAL # (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT OF A SPRAY OF FLUID UNDER PRESSURE NOT CONTAINED WITHIN THE INSTRUMENT. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 22FEB2020 TO DATE 22FEB2021. COMPLAINT TREND: THERE ARE 4 COMPLAINTS RELATED TO A SPRAY OF FLUID NOT CONTAINED WITHIN THE INSTRUMENT; DATE RANGE FROM 22FEB2020 TO DATE 22FEB2021. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 659180 SERIAL # (B)(6). FILE # 659180-659180-R659180000455-106296409-19, 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, RISK ANALYSIS AND SERVICEMAX, THE ROOT CAUSE OF THE SPRAY OF FLUID NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A BLOCKAGE IN THE V8 TUBING. THE TSR(TECHNICAL SERVICE REPRESENTATIVE) ASSISTING THE CUSTOMER HELPED GUIDE THEM TO REMOVE THE V8 HOSE FROM THE SIDE OF THE INSTRUMENT, RUN SEVERAL SIT FLUSHES, AND REATTACH THE HOSE. AFTER REATTACHING THE HOSE THE INSTRUMENT WAS WORKING AS INTENDED AND NO LONGER LEAKED DURING THE SIT FLUSH OPERATION. NO PARTS WERE REQUESTED FOR EVALUATION AS NO PARTS WERE REPLACED. ALTHOUGH A SPRAY OF FLUID CAN POSE A RISK TO THE CUSTOMER, THE PRESSURE OF THE SPRAY WAS NOT LARGE ENOUGH TO SIGNIFICANTLY INCREASE THE RISK OF EXPOSURE, AND THE LEAKED FLUID WAS NOT BIOHAZARDOUS AND WAS ONLY FACSFLOW. THE CUSTOMER WORE PROPER PPE DURING THE CLEANING OF THE LEAK, GLOVES AND LAB COATS, AND WERE NOT HARMED DUE TO THE INCIDENT IN ANY WAY. ADDITIONALLY, THIS INSTRUMENT IS AN RUO INSTRUMENT (RESEARCH USE ONLY), AND THUS WOULD NOT AFFECT OR DELAY THE TREATMENT OF A PATIENT. PROPER DAILY AND MONTHLY CLEANING AND OTHER MAINTENANCE CAN HELP REDUCE BLOCKAGE ISSUES, AND INSTRUCTIONS CAN BE FOUND IN FACSLYRIC¿S INSTRUCTIONS FOR USE, #23-19938-02 REV. 1/VERS. A. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: 01802035, CASE # 01271417 INSTALL DATE: 23OCT2019 DEFECTIVE PART NUMBER: N/A WORK ORDER NOTES: O SUBJECT / REPORTED: 659180 - FACSLYRIC 3L10C INSTRUMENT - WITH SIT FLUSH, FACSFLOW COMES OUT OF THE NEEDLE O PROBLEM DESCRIPTION: WITH A SIT FLUSH, FACSFLOW COMES OUT OF THE NEEDLE O WORK PERFORMED: OPEN THE LEFT SIDE WITH THE CUSTOMER, TAKE THE HOSE OUT OF THE V8 - DO A FEW SIT FLUSHES - WORK AGAIN => HOSE IS CORRECTLY INSERTED AGAIN AND TESTED AGAIN, SIT FLUSH WORKS AGAIN. O CAUSE: BLOCKAGE IN THE HOSE OF V8 O SOLUTION: V8 HOSE MADE FREE TO MOVE. RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THERE WERE NO PARTS REPLACED. RISK ANALYSIS: RISK MANAGEMENT FILE PART # 10000063058, REV. 03/VERS. X, BD FACSLYRIC SYSTEM RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATIONS ARE SUFFICIENT. HAZARD(S) IDENTIFIED? ¿YES ¿NO O AZURE ID: 89169 O ID: LIBIVD-RA-61 2.1.6 O REG STATUS: IVD; RUO O HAZARD: EXPOSURE TO BIOLOGICAL SAMPLE. O CAUSE: BACK DRIP FROM INJECTION PORT (SIT). O HARMFUL EFFECTS: HARM TO OPERATOR. (EXPOSURE TO STAINED SAMPLE). O RISK CONTROL: - SIT DESIGN TO CAPTURE BACK DRIPS. - PROVIDE INSTRUCTION FOR UNIVERSAL PRECAUTIONS. O REQ LINK (AZURE ID): 93132 LIBIVD-DID-262 SAMPLE PRESERVATION DURING PAUSE O IMPLEMENTATION VERIFICATION: - LSVN-1008-DP SIT BACKFLOW CONTROL - LIBIVD-SE-15-51IR O EFFECTIVENESS VERIFICATION: - LSVN-1008-DR - LIBIVD-SE-15-51IR O PROBABILITY: 1 O SEVERITY: 3 O RISK INDEX: 3 O RESIDUAL RISK EVALUATION: A O NEW HAZARDS: NONE MITIGATION(S) SUFFICIENT ¿YES ¿NO ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE SPRAY OF FLUID NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A BLOCKED V8 LINE. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE SPRAY OF FLUID NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A BLOCKED V8 LINE. A TSR ASSISTED THE CUSTOMER IN REPAIRING THE INSTRUMENT BY REMOVING THE V8 TUBING, RUNNING SIT FLUSHES, AND REATTACHING THE TUBING. AFTER THE REPAIR, THE INSTRUMENT WAS REBOOTED, TESTED, AND FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED SINCE THIS INSTRUMENT IS FOR RESEARCH USE ONLY. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO THE CUSTOMER HEALTH OR SAFETY. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD FACSLYRIC¿ FACSFLOW SPRAYED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WITH A SIT FLUSH, FACSFLOW COMES OUT OF THE NEEDLE 1.WAS THE LEAK LIQUID OR AIR? LIQUID 2.WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED 3.WAS THE SPRAY OF LIQUID UNDER PRESSURE? SPRAY, FACSFLOW 4.WHAT WAS THE FLUID THAT LEAKED? NON BIOHAZARD 5.DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE 6.WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO 7.WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? PHYSICAL CONTACT INCLUDES : CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION AND NON-INTACT SKIN. NO 8.WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? CLEANING THE DROPS FROM THE SIP THAT LANDED ON THE BENCHTOP 9.WHAT PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS BEING USED DURING THE OCCURANCE? GLOVES AND LABCOATS 10.WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? NO 11.WAS CUSTOMER/BD PERSONNEL HARMED/INJURED? NO 12.WHAT IS THE CURRENT MEDICAL STATUS?

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD FACSLYRIC¿ FACSFLOW SPRAYED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WITH A SIT FLUSH, FACSFLOW COMES OUT OF THE NEEDLE, WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THE SPRAY OF LIQUID UNDER PRESSURE? SPRAY, FACSFLOW. WHAT WAS THE FLUID THAT LEAKED? NON BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? PHYSICAL CONTACT INCLUDES : CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION AND NON-INTACT SKIN. NO. WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? CLEANING THE DROPS FROM THE SIP THAT LANDED ON THE BENCHTOP. WHAT PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS BEING USED DURING THE OCCURENCE? GLOVES AND LABCOATS. WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? NO. WAS CUSTOMER/BD PERSONNEL HARMED/INJURED? NO. WHAT IS THE CURRENT MEDICAL STATUS?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514460 BD FACSLYRIC NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1