BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACS SAMPLE PREP ASSISTANT II

    MDR report key: 11608076 · Received April 2, 2021

    Report

    Report Number
    2916837-2021-00137
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 9, 2021
    Report Date
    June 18, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    JQW
    PMA / PMN Number
    EXEMPT
    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# 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 FACS SAMPLE PREP ASSISTANT II BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WASH TOWER IS OVERFLOWING AT THE END OF THE RUN. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. (IF NOT CONTAINED) WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. WHAT IS THE SOURCE OF LEAK ¿ BEFORE WASTE LINE OR AFTER WASTE LINE? BEFORE WASTE LINE. -5B (IF WASTE LINE) ¿ WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? GLOVED HANDS. WHAT PERSONAL PPE WAS BEING USED DURING THE OCCURRENCE? GLOVES AND LAB COAT. WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? NO. WAS CUSTOMER/BD PERSONNEL HARMED/INJURED? NO.

    Additional Manufacturer Narrative · 1

    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 FACS SAMPLE PREP ASSISTANT II BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WASH TOWER IS OVERFLOWING AT THE END OF THE RUN. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. (IF NOT CONTAINED) WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. WHAT IS THE SOURCE OF LEAK  BEFORE WASTE LINE OR AFTER WASTE LINE? BEFORE WASTE LINE. -5B (IF WASTE LINE)  WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? 6. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO 7. WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? GLOVED HANDS. 8. WHAT PERSONAL PPE WAS BEING USED DURING THE OCCURRENCE? GLOVES AND LAB COAT. 9. WAS THERE ANY IMPACT TO PATIENT SAMPLES DUE TO LEAK? NO 10. WAS CUSTOMER/BD PERSONNEL HARMED/INJURED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507020 BD FACS SAMPLE PREP ASSISTANT II STATION, PIPPETTING DILUTING CLINICAL JQW BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1