BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSARIA FLOW CYTOMETER

    MDR report key: 11003732 · Received December 14, 2020

    Report

    Report Number
    2916837-2020-00303
    Event Type
    Malfunction
    Date Received
    December 14, 2020
    Date of Event
    November 20, 2020
    Report Date
    June 15, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW MFR#(B)(4) 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 THAT WHILE USING A BD FACSARIA¿ FLOW WASTE LEAKAGE WITHOUT BLEACH WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED THAT LIQUID IS DRIPPING FROM BEHIND THE WASTE DRAWER. 1. WAS THE LEAK LIQUID OR AIR? LIQUID 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO SPRAY OF LIQUID 4. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE 6. WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? NO 7. WAS THE CUSTOMER/ BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO 8. WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? GLOVED HAND 9. WHAT PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS BEING USED DURING THE OCCURRENCE? GLOVES 10. WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? NO 11. WAS CUSTOMER/ BD PERSONNEL HARMED/ INJURED? 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. FDA DEVICE PROBLEM CODE(S): 1250, FDA PATIENT PROBLEM CODE(S): 2199.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD FACSARIA¿ FLOW WASTE LEAKAGE WITHOUT BLEACH WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED THAT LIQUID IS DRIPPING FROM BEHIND THE WASTE DRAWER. 1. WAS THE LEAK LIQUID OR AIR? LIQUID 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO SPRAY OF LIQUID 4. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE 6. WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? NO 7. WAS THE CUSTOMER/ BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO 8. WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? GLOVED HAND 9. WHAT PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS BEING USED DURING THE OCCURRENCE? GLOVES 10. WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? NO 11. WAS CUSTOMER/ BD PERSONNEL HARMED/ INJURED? NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471184 BD FACSARIA FLOW CYTOMETER NA GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1