BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC

    MDR report key: 10843908 · Received November 16, 2020

    Report

    Report Number
    2916837-2020-00250
    Event Type
    Malfunction
    Date Received
    November 16, 2020
    Date of Event
    October 26, 2020
    Report Date
    June 17, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382906635181
    PMA / PMN Number
    K170974
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT ON THE SIT DRIPPING BIOHAZARD WITHOUT BLEACH DURING A SIT FLUSH. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 26OCT2019 TO DATE 26OCT2020. COMPLAINT TREND: THERE ARE NO OTHER COMPLAINTS ASIDE FROM THIS ONE, RELATED TO THE ABOVE PROBLEM. DATE RANGE FROM 26OCT2019 TO DATE 26OCT2020. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART #663518 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, RISK ANALYSIS AND SERVICEMAX, THE ROOT CAUSE OF THE SIT DRIPPING DURING SIT FLUSHES WAS A WORN PINCH VALVE TUBING. THE PINCH VALVE¿S DEFAULT STATE IS PINCHED SHUT, SO IF AN INSTRUMENT IS UNUSED FOR A PROLONGED AMOUNT OF TIME THIS TUBING WILL BE WORN, CLOSED SHUT OR NOT FULLY OPEN AND WILL HAVE TO EITHER BE EXERCISED AND RECONNECTED OR REPLACED ENTIRELY. THE FSE (FIELD SERVICE ENGINEER) OBSERVED THE ISSUE AND REPLACED THE PINCH VALVE TUBING. THEY THEN RAN MULTIPLE SIT FLUSHES TO CONFIRM THAT THE INSTRUMENT WAS NO LONGER DRIPPING, AND RAN PQC AND ABORT COUNT TESTS TO VERIFY THE INSTRUMENT WAS WORKING AS INTENDED. NO PARTS WERE REQUESTED FOR EVALUATION AS TUBING IS NOT FROM STOCK INVENTORY AND THE REPLACED TUBING WAS DISCARDED. ALTHOUGH LEAKAGE OF BIOHAZARD MATERIAL CAN CAUSE HARM TO THE CUSTOMER FROM EXPOSURE TO SAMPLES AND CHEMICALS, THE CUSTOMER WAS NOT HARMED IN ANY WAY FROM THIS INCIDENT AS THE LEAKAGE WAS MINIMAL. THE CUSTOMER/BD PERSONNEL CAME INTO CONTACT WITH THE FLUID ONLY WHEN CLEANING WITH APPROPRIATE PPE. THERE WAS NO IMPACT TO PATIENT SAMPLES DUE TO THIS LEAK, AND HAD NO IMPACT ON A PATIENT DIAGNOSIS DUE TO THE LEAK. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(4) INSTALL DATE: 21AUG2020. DEFECTIVE PART NUMBER: N/A. WORK ORDER NOTES: SUBJECT / REPORTED: SIT DRIP DURING SIT FLUSH PROBLEM DESCRIPTION: SIT DRIP DURING SIT FLUSH WORK PERFORMED: REPLACED PINCH VALVE TUBING. RAN MULTIPLE SIT FLUSHES RAN PQC AND ABORT COUNTS CAUSE: PINCH VALVE TUBING FOR THE SIP WASTE LINE WAS STUCK PINCHED STUCK, CAUSING WASTE FROM SIP FLUSHES TO DRIP OUT OF THE SIP. SOLUTION: NO MORE DRIPS. INSTRUMENT HAS PASSED ALL QC RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THE REPLACED PART IS NOT RETURNABLE AND WAS DISCARDED. RISK ANALYSIS: RISK MANAGEMENT FILE PART # 10000063058, VERS. X, BD FACSLYRIC SYSTEM RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATION IS SUFFICIENT. HAZARD(S) IDENTIFIED? YES. NO. TFS: (B)(4). ID: LIBIVD-RA-61 2.1.6. LIBIVD-RA-247 3.1.25. REG STATUS: IVD; RUO HAZARD EXPOSURE TO BIOLOGICAL SAMPLE. INSTRUMENT TEMPORARILY INOPERABLE. SOURCE: SIT FMEA. CAUSE BACK DRIP FROM INJECTION PORT (SIT). SAMPLE LINE COLLAPSES PREVENTING SAMPLE DELIVERY. TUBING BECOMES WORN/DAMAGED DURING "STINGER" OPERATION. LOW EVENT RATE. HARMFUL EFFECTS: HARM TO OPERATOR. (EXPOSURE TO STAINED SAMPLE). 1) DELAY IN RESULTS. 2) TUBING MUST BE REPLACED. 3) CUSTOMER ANNOYANCE. RISK CONTROL: SIT DESIGN TO CAPTURE BACK DRIPS. PROVIDE INSTRUCTION FOR UNIVERSAL PRECAUTIONS -PROPER SERVICE LOOPS FOR PEEKSIL TUBE SO THAT IT DOES NOT WEAR AND KINK AT THE CONNECTION POINTS. RELIABILITY TEST TO PROVIDE ESTIMATE LIFE OF PEEKSIL TUBE AND RECOMMENDED REPLACEMENT SCHEDULE. RELIABILITY SIT PROTOCOL REQ LINK (TFS ID): 93132 LIBIVD-DID-262 SAMPLE PRESERVATION DURING PAUSE IMPLEMENTATION VERIFICATION: LSVN-1008-DP SIT BACKFLOW CONTROL, LIBIVD-SE-15-51IR RELIABILITY LIFE TESTING COMPLETED VIA PROTOCOL. PROTOCOL NAME: LIBERTY SIT RELIABILITY TEST PROTOCOLLIBIVD-SE-15-72P EFFECTIVENESS VERIFICATION: LSVN-1008-DR, LIBIVD-SE-15-51IR PUBLISHED RELIABILITY REPORT WHICH DEMONSTRATED AT LEAST 1.5 YEARS OF LIFE WITH NO SIGNIFICANT DAMAGE OR KINKS. REPORT NAME: LIBERTY SIT RELIABILITY REPORT, LIBIVD-SE-15-72F LSV1004-DR PROBABILITY: 1 SEVERITY: 3 RISK INDEX: 3 RESIDUAL RISK EVALUATION: A NEW HAZARDS: NONE MITIGATION(S) SUFFICIENT YES. NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE DRIPPING SIT WAS DUE TO A WORN PINCH TUBING. CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE OF THE CUSTOMER OBSERVING THE SIT DRIPPING DURING THE SIT FLUSH WAS A WORN PINCH VALVE TUBE. THE FSE REPLACED THE PINCH VALVE TUBING, RAN MULTIPLE SIT FLUSHES, AND RAN PQC AND ABORT COUNT TESTS TO ENSURE THAT THE INSTRUMENT WAS WORKING AND NO LONGER DRIPPING FROM THE SIT. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO THE LEAKAGE. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO PATIENT HEALTH OR SAFETY. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ BIO HAZARD PRIOR TO WASTE LINE LEAKED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SIT DRIP DURING SIT FLUSH IS INSTRUMENT ASSURITY LINC ENABLED? N CUSTOMER PROBLEM: SIT DRIPS WHEN SIT FLUSH IS EXECUTED. THEY SEE ABOUT 2 OR 3 DROPS DROP ONTO THE TABLETOP. THIS BEGAN AFTER A MONTHLY MAINTENANCE. SAMPLES RUN FINE STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: THEY HAVE NOT ADJUSTED THE SAMPLE LINE AND WE CHECK3ED WASTE CONNECTIONS AND THEY LOOK FINE. NEXT STEPS (IF NECESSARY): DISPATCH ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? N WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? N WAS THERE ANY INJURY OR POTENTIAL INJURY? N LEAK (IF YES EXPLAIN)? N RESOLUTION ACHIEVED (Y/N)? N FOLLOW UP REQUIRED (Y/N)? Y LIST OF PARTS SHIPPED (INCLUDE FOC): N/A RMA REQUIRED (Y/N)? N/A 1. WAS THE LEAK LIQUID OR AIR? LIQUID 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO 3. (IF NOT CONTAINED) WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO 4. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN 5. WHAT IS THE SOURCE OF LEAK ¿ BEFORE WASTE LINE OR AFTER WASTE LINE? BEFORE WASTE LINE 6. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO 1. WAS THE LEAK LIQUID OR AIR? LIQUID 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO 3. (IF NOT CONTAINED) WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO 4. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD 5. WHAT IS THE SOURCE OF LEAK ¿ BEFORE WASTE TANK OR AFTER WASTE TANK? BEFORE WASTE LINE -5B (IF WASTE LINE) ¿ WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? NO 6. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? YES 7. WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? CLEANING THE DROPS FROM THE SIP THAT LANDED ON THE BENCHTOP 8. WHAT PERSONAL PPE WAS BEING USED DURING THE OCCURRENCE? 9. WAS THERE ANY IMPACT TO PATEINT SAMPLES DUE TO LEAK? NO.

    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 WHILE USING BD FACSLYRIC¿ BIO HAZARD PRIOR TO WASTE LINE LEAKED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SIT DRIP DURING SIT FLUSH; IS INSTRUMENT ASSURITY LINC ENABLED? NO. CUSTOMER PROBLEM: SIT DRIPS WHEN SIT FLUSH IS EXECUTED. THEY SEE ABOUT 2 OR 3 DROPS DROP ONTO THE TABLETOP. THIS BEGAN AFTER A MONTHLY MAINTENANCE. SAMPLES RUN FINE STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: THEY HAVE NOT ADJUSTED THE SAMPLE LINE AND WE CHECKED WASTE CONNECTIONS AND THEY LOOK FINE. NEXT STEPS (IF NECESSARY): DISPATCH. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? NO. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. LEAK (IF YES EXPLAIN)? NO. RESOLUTION ACHIEVED (Y/N)? NO. FOLLOW UP REQUIRED (Y/N)? Y LIST OF PARTS SHIPPED (INCLUDE FOC): N/A. RMA REQUIRED (Y/N)? N/A. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. (IF NOT CONTAINED) WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. WHAT IS THE SOURCE OF LEAK ¿ BEFORE WASTE LINE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? CLEANING THE DROPS FROM THE SIP THAT LANDED ON THE BENCHTOP. WHAT PERSONAL PPE WAS BEING USED DURING THE OCCURRENCE? 9. WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310022 BD FACSLYRIC FLOW CYTOMETRIC REAGENTS & ACCESS. OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA 00382906635181

    Patients

    Seq Age Sex Outcome Treatment
    1