BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTO ADMIN 4 LINE SET C110

    MDR report key: 9618156 · Received January 22, 2020

    Report

    Report Number
    2243072-2020-00071
    Event Type
    Malfunction
    Date Received
    January 22, 2020
    Date of Event
    December 3, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLE WAS AVAILABLE FOR INVESTIGATION,AND A PICTURE WAS NOT PROVIDED FOR EVALUATION. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER K74114-1 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 THE DEVICE. UNFORTUNATELY, A DEFECTIVE VALVE COULD ONLY BE TESTED IF WE HAD THE OFFENDING SAMPLE. NO SAMPLE WAS AVAILABLE FOR THE INVESTIGATION. 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 CYTO ADMIN 4 LINE SET C110 HAD FLOW ISSUES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: ¿WHEN C110 IS CONNECTED TO RUBICINE INFUSION AND THE INFUSION IS STARTED, THE FLOW OF THE DRUG IS NOT MOVING. NURSE ENDED UP CHANGING TO ANOTHER NEW C110 SET AND FLOW WAS NORMAL.¿

    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 AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED CYTO ADMIN 4 LINE SET C110 HAD FLOW ISSUES DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: ¿WHEN C110 IS CONNECTED TO RUBICINE INFUSION AND THE INFUSION IS STARTED, THE FLOW OF THE DRUG IS NOT MOVING. NURSE ENDED UP CHANGING TO ANOTHER NEW C110 SET AND FLOW WAS NORMAL.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82678 CYTO ADMIN 4 LINE SET C110 INTRAVASACULAR ADMINISTRATION SET FPA BECTON DICKINSON K74114-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other