BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE®

    MDR report key: 8799484 · Received July 17, 2019

    Report

    Report Number
    2523676-2019-00125
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    June 20, 2019
    Report Date
    August 29, 2019
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    KPE
    UDI-DI
    04046964200700
    PMA / PMN Number
    K041415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). ONE (1) COMPOUNDED BAG WAS RECEIVED FOR EVALUATION. WHEN THE COMPOUNDED SOLUTION WAS FILTERED, BLACKISH PARTICLES WERE FOUND IN THE BAG. THE PARTICLES WERE TOO SMALL TO ANALYZE UNDER FT-IR ANALYSIS. THERE WERE NO PRODUCT DEVIATIONS, AND THE PARTICLES COULD NOT BE ATTRIBUTED TO THE PRODUCTION PROCESS. SINCE THE BAGS HAD BEEN FILLED, IT IS POSSIBLE THAT THE CONTAMINATION OCCURRED DURING THE FILLING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: ONE BAG HAD CORING INSIDE. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594815 PINNACLE® CONTAINER, I.V. KPE B. BRAUN MEDICAL INC. 2112349 18L23 04046964200700

    Patients

    Seq Age Sex Outcome Treatment
    1