BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE®

    MDR report key: 15442507 · Received September 16, 2022

    Report

    Report Number
    2523676-2022-00451
    Event Type
    Malfunction
    Date Received
    September 16, 2022
    Date of Event
    August 16, 2022
    Report Date
    June 29, 2023
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    NEP
    UDI-DI
    04046964447198
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT 400565973. THE DEVICE WAS NOT RETURNED FOR EVALUATION. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE WITHOUT A DEVICE. IF THE DEVICE DOES BECOME AVAILABLE, THE COMPLAINT WILL BE REOPENED FOR FURTHER EVALUATION. ALL INFORMATION CONCERNING THIS REPORTED INCIDENT HAS BEEN INCLUDED IN OUR TREND ANALYSIS OF THE PRODUCT LINE.

    Additional Manufacturer Narrative · 0

    THIE REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: CUSTOMER CALLED TO REPORT HAVING AN ISSUE WITH 35ML OF A SOLUTION BEING MISTAKENLY ADDED TO A FRESHLY HUNG FINAL CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176631 PINNACLE® PINNACLE® TPN MANAGEMENT SYSTEM, NEP B. BRAUN MEDICAL INC. PC1000 04046964447198

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown