BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSLYRIC

    MDR report key: 11716603 · Received April 23, 2021

    Report

    Report Number
    2916837-2021-00193
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    April 4, 2021
    Report Date
    May 5, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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# 2916837-2021-00193 WAS SENT IN ERROR. THE FSE CONFIRMED THAT THE LEAKAGE WAS CONTAINED WITHIN INSTRUMENT, THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE ARE PQC FAILURES AND FLUID IS DRIPPED FROM THE SAMPLE PROBE DURING CLEANING. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED? WASTE. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE LINE. 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. WAS THE FLUID SPRAYING OUT FROM THE POINT OF THE LEAK? NO. WAS THE WASTE MIXED WITH DECONTAMINATION / BLEACH SOLUTION? UNKNOWN. WAS PROPER PPE BEING WORN AT TIME OF LEAK AND DURING CLEAN UP? YES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WHILE USING BD FACSLYRIC¿ WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE ARE PQC FAILURES AND FLUID IS DRIPPED FROM THE SAMPLE PROBE DURING CLEANING. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED? WASTE. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE LINE. 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. WAS THE FLUID SPRAYING OUT FROM THE POINT OF THE LEAK? NO. WAS THE WASTE MIXED WITH DECONTAMINATION / BLEACH SOLUTION? UNKNOWN. WAS PROPER PPE BEING WORN AT TIME OF LEAK AND DURING CLEAN UP? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617646 BD FACSLYRIC NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1