BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD TUBING

    MDR report key: 12006076 · Received June 15, 2021

    Report

    Report Number
    2243072-2021-01680
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    April 22, 2021
    Report Date
    June 23, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT THERE WAS AIR ALL THE WAY TO THE DISTAL END OF THE PUMP CHANNEL. THE CUSTOMER COMPLAINT 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 OR LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD¿ TUBING HAD AIR IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS AIR ALL THE WAY TO THE DISTAL END OF THE PUMP CHANNEL. VERBATIM: AT THE BEGINNING OF RN'S SHIFT, A NEW FENTANYL BAG WAS HUNG NEW TUBING WAS NOT NEEDED, SO IT WAS A FULL LOOML BAG. AT 0550 THE IV PUMP CHANNEL ALARMED FLUID SIDE EMPTY. THERE WAS AIR ALL THE WAY TO THE DISTAL END OF THE PUMP CHANNEL, THE BAG WAS EMPTY, THE TUBING CHAMBER WAS COLLAPSING ON ITSELF, HOWEVER THERE WAS STILL 20ML TO BE INFUSED. A NEW BAG WAS HUNG. DAY SHIFT RN WAS AWARE OF THE ISSUE, SHOULD IT HAPPEN AGAIN. THE CHANNEL ALARMED AIR IN LINE FOR DAY SHIFT RN AND BAG WAS EMPTY WITH APPROX IML VTBI. CONCERNS MADE BY THIS RN TO NURSE MANAGER AT BEGINNING OF NOC SHIFT. CHANNEL CHANGED OUT AND WORK ORDER PLACED.

    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) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 18 MAY, 2021. MEDWATCH REPORT # (B)(4). REPORT SOURCE OTHER: MEDWATCH REPORT. 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 UNSPECIFIED BD¿ TUBING HAD AIR IN THE LINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE WAS AIR ALL THE WAY TO THE DISTAL END OF THE PUMP CHANNEL. VERBATIM: AT THE BEGINNING OF RN'S SHIFT, A NEW FENTANYL BAG WAS HUNG NEW TUBING WAS NOT NEEDED, SO IT WAS A FULL LOOML BAG. AT 0550 THE IV PUMP CHANNEL ALARMED FLUID SIDE EMPTY. THERE WAS AIR ALL THE WAY TO THE DISTAL END OF THE PUMP CHANNEL, THE BAG WAS EMPTY, THE TUBING CHAMBER WAS COLLAPSING ON ITSELF, HOWEVER THERE WAS STILL 20ML TO BE INFUSED. A NEW BAG WAS HUNG. DAY SHIFT RN WAS AWARE OF THE ISSUE, SHOULD IT HAPPEN AGAIN. THE CHANNEL ALARMED AIR IN LINE FOR DAY SHIFT RN AND BAG WAS EMPTY WITH APPROX IML VTBI. CONCERNS MADE BY THIS RN TO NURSE MANAGER AT BEGINNING OF NOC SHIFT. CHANNEL CHANGED OUT AND WORK ORDER PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893874 UNSPECIFIED BD TUBING INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1