BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSMELODY

    MDR report key: 11645663 · Received April 9, 2021

    Report

    Report Number
    2916837-2021-00166
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 19, 2021
    Report Date
    July 12, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW MFR#:2916837-2021-00166 IS NO LONGER REPORTABLE. THIS DEVICE IS FOR RESEARCH USE ONLY AND IS NOT BEING USED FOR DIAGNOSTIC TESTING OR PATIENT TREATMENT AND IS THEREFORE NOT SUBJECT TO MDR REPORTING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD FACSMELODY¿ BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. LEAK ON SAMPLES: WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? NO . DID THE BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. ADDITIONALLY, THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER STATES THEY HAD A EVENT RATE ISSUE-CTS REMOTED INTO THE INSTRUMENT, DID MULTIPLE SAMPLE LINE BACK FLUSHES. VERIFIED SAMPLE FLOW RATE, ALL SAT. BUT CUSTOMER STATES WHEN THE SAMPLE LINE DOES A BACK FLUSH, THE BI CHAMBER ASPIRATOR CUP WAS DRIPPING FLUID. CTS DID MULTIPLE SAMPLE LINE BACK FLUSHES, STILL DRIPPING FLUID, HAD CUSTOMER, HAD CUSTOMER OPEN THE SORT CHAMBER DOOR, CUSTOMER STATES THE SORT CHAMBER ASPIRATOR IS DRAINING PROPERLY. RESOLUTION NOT ACHIEVED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD FACSMELODY¿ BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. LEAK ON SAMPLES. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? NO . DID THE BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. ADDITIONALLY, THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: CUSTOMER STATES THEY HAD A EVENT RATE ISSUE-CTS REMOTED INTO THE INSTRUMENT, DID MULTIPLE SAMPLE LINE BACK FLUSHES. VERIFIED SAMPLE FLOW RATE, ALL SAT. BUT CUSTOMER STATES WHEN THE SAMPLE LINE DOES A BACK FLUSH, THE BI CHAMBER ASPIRATOR CUP WAS DRIPPING FLUID. CTS DID MULTIPLE SAMPLE LINE BACK FLUSHES, STILL DRIPPING FLUID, HAD CUSTOMER, HAD CUSTOMER OPEN THE SORT CHAMBER DOOR, CUSTOMER STATES THE SORT CHAMBER ASPIRATOR IS DRAINING PROPERLY. RESOLUTION NOT ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543224 BD FACSMELODY NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1