BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTO ADMIN 4 LINE SET C110

    MDR report key: 9587069 · Received January 14, 2020

    Report

    Report Number
    2243072-2020-00028
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 23, 2019
    Report Date
    April 3, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLE WAS AVAILABLE FOR INVESTIGATION, BUT A PICTURE WAS PROVIDED FOR EVALUATION. THERE WAS A KNOWN ISSUE IDENTIFIED FOR THE REPORTED LOT K74114-1 . THE COMPLAINT REFERS TO THE SAME BATCH WHICH WAS MANUFACTURED IN 2017, AND AT THAT TIME THE SUPPLIER OCCASIONALLY EXPERIENCED BLOCKING VALVES ALTHOUGH THEY HAD ALL 100% BEEN TESTED FOR FUNCTIONALITY BEFORE THEY LEFT THE PREMISES. CORRECTIVE ACTION WAS TAKEN BY OPTIMIZING THE COMPOUNDING PROCESS FOR THIS DEVICE. THE PICTURE SHOWED A CYTO-AD Z® INLINE/4 SET, CONNECTED TO A SEMI RIGID-CONTAINER, WHICH WAS ABOUT 2/3 EMPTY. CONNECTED TO ONE OF THE Y-PORTS WAS A TRANSFER SYSTEM BEING CONNECTED AT THE OTHER END TO ANOTHER SEMI RIGID CONTAINER WHICH WAS ALMOST COMPLETELY EMPTY. IT CONTAINED A RESIDUAL AMOUNT OF A YELLOWISH SOLUTION WHICH WAS ALSO VISIBLE IN THE TUBING OF THE TRANSFER LINE. ON THE PICTURE WE CAN¿T IDENTIFY ANY INDICATION FOR A MISTAKE OF THE VALVE. THE SYSTEM SEEMS TO HAVE FUNCTIONED PROPERLY (EMPTY CONTAINER!). BECAUSE THE CUSTOMER DESCRIBED THAT AFTER CHANGING THE CYTO-AD Z® INLINE/4, THE SYSTEM FUNCTIONED WELL, WE GUESS, THE PICTURE WAS RATHER TAKEN FROM THE SET WHICH WORKED WELL. HOWEVER, A DEFECTIVE VALVE COULD ONLY BE TESTED IF WE HAD THE OFFENDING SAMPLE, WHICH WAS UNFORTUNATELY NOT AVAILABLE. NO SAMPLE WAS AVAILABLE FOR THE INVESTIGATION AND NO FURTHER EVALUATION AT THIS TIME WAS POSSIBLE. THE POSSIBLE ROOT CAUSE WAS RELATED TO A DEFECTIVE LOT, HOWEVER THE ACTUAL ROOT CAUSE WAS UNCONFIRMED. BD WILL CONTINUE TO MONITOR FOR ANY TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE CYTO ADMIN 4 LINE SET C110 THERE WAS AN ISSUE WITH FLOW OBSTRUCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CONNECTING TO THE IV LINE AND CHEMO LINE, THE CHEMO COULD NOT FLOW WELL. AFTER CHANGING TO DIFFERENT C110, THEN THE CHEMO COULD RUN PROPERLY.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE CYTO ADMIN 4 LINE SET C110 THERE WAS AN ISSUE WITH FLOW OBSTRUCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER CONNECTING TO THE IV LINE AND CHEMO LINE, THE CHEMO COULD NOT FLOW WELL. AFTER CHANGING TO DIFFERENT C110, THEN THE CHEMO COULD RUN PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52597 CYTO ADMIN 4 LINE SET C110 INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON K74114-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other