BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ARIA III 3B/3R/3V/5YG

    MDR report key: 10388135 · Received August 10, 2020

    Report

    Report Number
    2916837-2020-00083
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 14, 2020
    Report Date
    November 17, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    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

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT # 2916837-2020-00083 WAS SENT IN ERROR. FSE PROVIDED VERIFICATION THAT LEAKAGE OCCURRED ENTIRELY WITHIN INSTRUMENT, THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PBS THAT WAS UNDER PRESSURE LEAKED OUTSIDE OF INSTRUMENT DURING USE WITH A BD ARIA¿ III 3B/3R/3V/5YG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING MAINTENANCE FOUND THAT THE HV BOARD IS DEFECTIVE. ADDITIONALLY, ON 2020-7-31 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? NO. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? YES. 4. WHAT WAS THE FLUID THAT LEAKED? PBS SIMILAR TO FACSFLOW, NO BIOHAZARD OR DANGEROUS FLUIDICS. 5. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? NO. 6. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. 7. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE 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. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PBS THAT WAS UNDER PRESSURE LEAKED OUTSIDE OF INSTRUMENT DURING USE WITH A BD ARIA¿ III 3B/3R/3V/5YG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING MAINTENANCE FOUND THAT THE HV BOARD IS DEFECTIVE. ADDITIONALLY, ON (B)(6) 2020 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? NO. WAS THERE SPRAY OF FLUID UNDER PRESSURE? YES. WHAT WAS THE FLUID THAT LEAKED? PBS SIMILAR TO FACSFLOW, NO BIOHAZARD OR DANGEROUS FLUIDICS. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? NO. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853346 BD ARIA III 3B/3R/3V/5YG NA GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other