BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCELESTA

    MDR report key: 11904589 · Received May 28, 2021

    Report

    Report Number
    2916837-2021-00259
    Event Type
    Malfunction
    Date Received
    May 28, 2021
    Date of Event
    May 7, 2021
    Report Date
    June 17, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    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 REVIEW MFR#2916837-2021-00259 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 THE BD FACSCELESTA¿ WAS LEFT ON OVERNIGHT AND BIOHAZARDOUS WASTE UNDER PRESSURE SPRAYED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: 1- WAS THE LEAK LIQUID OR AIR? LIQUID; 2- WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED; 3- WAS THERE SPRAY OF LIQUID UNDER PRESSURE? YES, WASTE WAS UNDER PRESSURE; 4- WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD; 5- DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE; 6- WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO. THE DEVICE WAS ACCIDENTALLY LEFT ON OVERNIGHT AND RAN EMPTY AND THE WASTE APPEARS TO HAVE OVERFLOWED. THE 20L WASTE CONTAINER WAS FULL AND THEN THE WASTE ACCUMULATED UNTIL THE 4L TABLE SIZZLING TANK OVERFLOWED.

    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 THAT THE BD FACSCELESTA¿ WAS LEFT ON OVERNIGHT AND BIOHAZARDOUS WASTE UNDER PRESSURE SPRAYED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: WAS THE LEAK LIQUID OR AIR? LIQUID; WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED; WAS THERE SPRAY OF LIQUID UNDER PRESSURE? YES, WASTE WAS UNDER PRESSURE; WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD; DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE; WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO. THE DEVICE WAS ACCIDENTALLY LEFT ON OVERNIGHT AND RAN EMPTY AND THE WASTE APPEARS TO HAVE OVERFLOWED. THE 20L WASTE CONTAINER WAS FULL AND THEN THE WASTE ACCUMULATED UNTIL THE 4L TABLE SIZZLING TANK OVERFLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801823 BD FACSCELESTA NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1