BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET

    MDR report key: 14155019 · Received April 20, 2022

    Report

    Report Number
    2243072-2022-00511
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 25, 2022
    Report Date
    May 9, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT THEY ARE EXPERIENCING CLOGGING WITH THE INTRALIPIDS. 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 MODEL AND LOT NUMBERS ARE UNKNOWN. 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 · 0

    IT WAS REPORTED THAT AT LEAST ONE UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSES DO RUN LIPIDS VIA PIV ¿ WHEN ACCESS IS LIMITED. WE HAVE BEEN EXPERIENCING A LOT OF CLOGGING WITH INTRALIPIDS AND THE BD CAREFUSION FILTERED LINES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST ONE UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NURSES DO RUN LIPIDS VIA PIV ¿WHEN ACCESS IS LIMITED. WE HAVE BEEN EXPERIENCING A LOT OF CLOGGING WITH INTRALIPIDS AND THE BD CAREFUSION FILTERED LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266151 UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown