BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE®

    MDR report key: 17461237 · Received August 4, 2023

    Report

    Report Number
    2523676-2023-00042
    Event Type
    Malfunction
    Date Received
    August 4, 2023
    Date of Event
    January 19, 2023
    Report Date
    August 4, 2023
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    NEP
    UDI-DI
    04046964957437
    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

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT NUMBER (B)(4). 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

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED TPN FINAL CONTAINERS WERE CLOUDY AT THE COMPLETION OF COMPOUNDING, BAGS WERE SCRAPPED AND REPUMPED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890697 PINNACLE® FINAL ASSEMBLY - PUMP MODULE NEP B. BRAUN MEDICAL INC. 04046964957437

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown