BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED BD TUBING

    MDR report key: 10897905 · Received November 24, 2020

    Report

    Report Number
    2243072-2020-01925
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    September 15, 2020
    Report Date
    November 10, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(4)), USA HAS BEEN USED AS A DEFAULT. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 20 OCTOBER, 2020. MEDWATCH REPORT # MW5097119. REPORT SOURCE OTHER: MEDWATCH REPORT. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT THAT AN INCREASING NUMBER OF CHANNEL DISCONNECTS, COMMUNICATION AND DEVICE SHUT DOWN ERRORS ARE BEING DISPLAYED WHILE USING THE BD CAREFUSION LARGE VOLUME/SYRINGE PUMPS COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A MODEL AND LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. INVESTIGATION CONCLUSION: THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD¿ TUBING HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: UNKNOWN BATCH/ LOT #: UNKNOWN. IT WAS REPORTED THAT AN INCREASING NUMBER OF CHANNEL DISCONNECTS, COMMUNICATION AND DEVICE SHUT DOWN ERRORS ARE BEING DISPLAYED WHILE USING THE BD CAREFUSION LARGE VOLUME/SYRINGE PUMPS. VERBATIM: CLINICAL TEAMS REPORT AN INCREASING NUMBER OF CHANNEL DISCONNECTS, COMMUNICATION AND DEVICE SHUT DOWN ERRORS WHILE USING THE BD CAREFUSION LARGE VOLUME/SYRINGE PUMPS THE ISSUE OCCURS DURING PUMP MOVEMENT AND WILE STATIONARY WHILE THE ERRORS ARE SIMILAR TO THOSE REPORTED IN THE RECENT RECALL NOTIFICATIONS, BD HAS AUDITED OUR CENTRALIZED PUMP CLEANING AND MAINTENANCE PROCESS WITH NO CONCLUSIVE FINDINGS THE AFFECTED EQUIPMENT IS FREE OF THE DAMAGE AND IUI CORROSION NOTED AS CAUSE IN THE RECALL. THE PUMPS ARE APPROXIMATELY SIX YEARS OLD ANS WELL WITHIN THE EXPECTED SERVICE LIFE CURRENT MITIGATION INCLUDE RESCUE CODE MEDICATIONS NEAR BEDSIDE, INCREASED MONITORING/ SURVEILLANCE/ MAINTENANCE, STAGING EMERGENCY BACKUP PUMPS ON THE UNITS, AND COORDINATION BETWEEN CLINICAL, PATIENT SAFETY AND SUPPORT STAFF FDA SAFETY REPORT ID # (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363070 UNSPECIFIED BD TUBING INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention