BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD OPTIMA

    MDR report key: 11758327 · Received April 30, 2021

    Report

    Report Number
    3003152976-2021-00243
    Event Type
    Malfunction
    Date Received
    April 30, 2021
    Date of Event
    December 12, 2020
    Report Date
    May 10, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FPA
    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

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. AS THE LOT INVOLVED IN THIS INCIDENT IS UNKNOWN, A DEVICE HISTORY REVIEW CANNOT BE PERFORMED, AND ADDITIONAL RETAINED SAMPLES CANNOT BE EVALUATED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED BD OPTIMA LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT WHILE PRIMING ETOPOSIDE, CHEMO BEGAN TO LEAK THROUGH BETWEEN PHASEAL AND BACKCHECK VALVE ONTO CHEMOTHERAPY PREP STATION.   VERBATIM: WHILE PRIMING ETOPOSIDE, CHEMO BEGAN TO LEAK THROUGH BETWEEN PHASEAL AND BACKCHECK VALVE ONTO CHEMOTHERAPY PREP STATION. PRIMING WAS STOPPED, CHARGE NURSE NOTIFIED. PHARMACY WAS NOTIFIED AND NEW BAG SENT. AND HELPED TO CLEAN THE SPILL."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD OPTIMA LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT WHILE PRIMING ETOPOSIDE, CHEMO BEGAN TO LEAK THROUGH BETWEEN PHASEAL AND BACKCHECK VALVE ONTO CHEMOTHERAPY PREP STATION.   WHILE PRIMING ETOPOSIDE, CHEMO BEGAN TO LEAK THROUGH BETWEEN PHASEAL AND BACKCHECK VALVE ONTO CHEMOTHERAPY PREP STATION. PRIMING WAS STOPPED, CHARGE NURSE NOTIFIED. PHARMACY WAS NOTIFIED AND NEW BAG SENT. AND HELPED TO CLEAN THE SPILL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649174 UNSPECIFIED BD OPTIMA INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1