BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCANTO¿ II

    MDR report key: 15385076 · Received September 8, 2022

    Report

    Report Number
    2916837-2022-00237
    Event Type
    Malfunction
    Date Received
    September 8, 2022
    Date of Event
    August 19, 2022
    Report Date
    December 6, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382903389629
    PMA / PMN Number
    K141468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY . INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO BD FACSCANTO II CYTOMETER 4/2/2 SYS IVD, PART # 338962, AND SERIAL # (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING A WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 19AUG2021 TO 19AUG2022. COMPLAINT TREND: THERE ARE 25 COMPLAINTS RELATED TO THE ABOVE PROBLEM. DATE RANGE FROM 19AUG2021 TO 19AUG2022. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART #338962, SERIAL # (B)(6) FILE # 338963-V96300969-900226743-10, 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 LEAKAGE NOT CONTAINED WAS DUE TO A BROKEN SHEATH LINE COUPLING ON THE LEFT SIDE OF THE MAIN BODY. THE CUSTOMER REPORTED A COMPLAINT REGARDING LIQUID LEAKING FROM THE LEFT SIDE OF THE BOTTOM OF THE MAIN UNIT. THEY WERE ADVISED BY BD TO REFRAIN USING THE INSTRUMENT AS MUCH AS POSSIBLE SINCE THERE WAS A POSSIBILITY OF WASTE LIQUID. A FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED. THE FIELD SERVICE REPRESENTATIVE (FSR) CHECKED THE STATUS OF THE INSTRUMENT, ITS OPERATION AND THE CV VALUES. THEY OBSERVED FLUID LEAKAGE INSIDE THE RIGHT DOOR OF THE MAIN UNIT AND PROCEEDED TO EXCHANGE THE RESTRICTOR WHICH IS CAPTURED IN A SEPARATE (B)(4). IN AN ATTEMPT TO RESOLVE THE LEAK (B)(4) THEY PERFORMED A SHEATH LINE COUPLING REPLACEMENT. AFTER THE WORKS PERFORMED, IT IS CONFIRMED THAT THE ISSUES HAVE BEEN RESOLVED AND THAT THE INSTRUMENT IS PERFORMING AS INTENDED. NO USER WAS HARMED OR INJURED AS A RESULT OF THE LEAK AND NO MEDICAL TREATMENT WAS PERFORMED. BD FACSCANTO II INSTRUCTIONS FOR USE (IFU), #23-20269-00 REV. 01/VERS. A, INDICATES TO WEAR SUITABLE PROTECTIVE CLOTHING AND GLOVES TO PREVENT TRANSMISSION OF POTENTIAL FATAL DISEASE FROM BIOLOGICAL SPECIMENS. THIS CAN BE FOUND ON PAGE 147 IN CLEANING THE SURFACES. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: (B)(4), CASE # (B)(4). INSTALL DATE: 11MAR2010 DEFECTIVE PART NUMBER: 59-10092-02 - CPLN BDY PNL MT 1/8 JD BLU 339294 - RESTRICTOR INLINE.010IN ID 1/16 TUBE YEL WORK ORDER NOTES: O SUBJECT / REPORTED: LIQUID LEAKING FROM THE LEFT SIDE OF THE BOTTOM OF THE MAIN UNIT. O PROBLEM DESCRIPTION: LIQUID LEAKING FROM THE LEFT SIDE OF THE BOTTOM OF THE MAIN UNIT O WORK PERFORMED: "(TREATMENT) ·CONFIRMATION OF CONDITION ·REPLACEMENT OF SHEATH LINE COUPLING ·CONFIRMATION OF OPERATION·CONFIRMATION OF CV VALUE BY ULTRARAINBOWBEADS. OTHERS 1. LEAKAGE OF RESTRICTOR INSIDE THE RIGHT DOOR OF THE MAIN BODY ¿REPLACEMENT" "(RESULT) THE PROBLEM HAS BEEN RESOLVED." O CAUSE: "(PHENOMENON) LEAKAGE FROM THE LEFT SIDE OF THE BOTTOM OF THE MAIN BODY" O SOLUTION: "(RESULT) THE PROBLEM HAS BEEN RESOLVED." ¿ RETURNED SAMPLE EVALUATION: THE COMPLAINT SAMPLE WAS NOT REQUESTED TO BE RETURNED BECAUSE THE REPLACED PARTS ARE NOT RETURNABLE AND WERE DISCARDED. ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART # 338942RA, REV. 09/VERS. H, BD FACSCANTO PRODUCT FAMILY RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATIONS ARE SUFFICIENT. HAZARD(S) IDENTIFIED? ¿YES ¿NO. O ID: (B)(4). O HAZARD: POTENTIAL LEAKAGE. O CAUSE: POTENTIAL LACK OF WORKMANSHIP DURING ASSEMBLY. O HARMFUL EFFECTS: POTENTIAL BIOHAZARD EXPOSURE. O RESIDUAL PROBABILITY : 1. O RESIDUAL SEVERITY :4. O RESIDUAL RISK INDEX: 4. ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE NOT CONTAINED WAS DUE TO A BROKEN SHEATH LINE COUPLING ON THE LEFT SIDE OF THE MAIN BODY. CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE OF THE LEAKAGE NOT CONTAINED WAS DUE TO A BROKEN SHEATH LINE COUPLING ON THE LEFT SIDE OF THE MAIN BODY. THE FSR PERFORMED A SHEATH LINE COUPLING REPLACEMENT AND EXCHANGED THE RESTRICTOR. AFTER THE WORKS PERFORMED, IT IS CONFIRMED THAT THE ISSUES HAVE BEEN RESOLVED AND THAT THE INSTRUMENT IS PERFORMING AS INTENDED. SUPPORTING DOCUMENT: N/A H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED WHILE USING BD FACSCANTO¿ II, THERE WAS A WASTE LEAK WITHOUT BLEACH, NOT CONTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6). PLEASE CONFIRM THE SAFETY CHECK BELOW. 1. WAS THE LEAK FLUID OR AIR? FLUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT¿NO. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED?BIOHAZARD. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. 6. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? NO. 7. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. (B)(6): (B)(6) 2022 01:14:20 (GMT) LIQUID LEAKING FROM THE LEFT SIDE OF THE BOTTOM OF THE MAIN UNIT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD FACSCANTO¿ II, THERE WAS A WASTE LEAK WITHOUT BLEACH, NOT CONTAINED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6), (B)(6) 2022. PLEASE CONFIRM THE SAFETY CHECK BELOW. WAS THE LEAK FLUID OR AIR? FLUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. (B)(6) : (B)(6) 2022 01:14:20 (GMT). LIQUID LEAKING FROM THE LEFT SIDE OF THE BOTTOM OF THE MAIN UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2108186 BD FACSCANTO¿ II COUNTER, DIFFERENTIAL CELL OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 338962 NA 00382903389629

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown