BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INFUSION SET

    MDR report key: 15991933 · Received December 15, 2022

    Report

    Report Number
    2243072-2022-02160
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Date of Event
    November 19, 2022
    Report Date
    January 11, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT THAT THERE WAS A FAULTY TUBING 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. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD INFUSION SET BAG WAS EMPTY ABOUT 4 HOURS LATER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEW BAG WAS STARTED AT 11/19 @ 1717, THEN FOUND BAG EMPTY ABOUT 4 HOURS LATER. THE RATE GOING 2.99 ML/HR SHOULD FALL MORE THAN THAT TIME

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD INFUSION SET BAG WAS EMPTY ABOUT 4 HOURS LATER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEW BAG WAS STARTED AT 11/19 @ 1717, THEN FOUND BAG EMPTY ABOUT 4 HOURS LATER. THE RATE GOING 2.99 ML/HR SHOULD FALL MORE THAN THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570453 UNSPECIFIED BD INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male