BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX®

    MDR report key: 18268724 · Received December 5, 2023

    Report

    Report Number
    2523676-2023-00750
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    November 3, 2023
    Report Date
    June 5, 2024
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    NEP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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, AND THE DEVICE LOGS WERE NOT MADE AVAILABLE. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE WITHOUT A DEVICE FOR EVALUATION OR THE DEVICE LOGS. IF THE DEVICE OR THE DEVICE LOGS DO 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 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: BRIEF INQUIRY DESCRIPTION: INCORRECT NATIONAL DRUG CODE (NDC) IN DELIVERY FACTOR DEVELOPMENT. DETAILED INQUIRY DESCRIPTION: CUSTOMER REQUESTED DELIVERY FACTORS (DF) FOR A HEPARIN DILUTION COMPOUNDED AT THEIR FACILITY. THE PRODUCT SENT TO THE B. BRAUN MEDICAL INC. (BBMI) CARROLTON FACILITY WAS LABELED AS HEPARIN IN 0.45% NORMAL SALINE (NS) (B)(4) UNITS PER MILLILITER (UNITS/ML). THE HEPARIN DILUTION WAS COMPOUNDED USING NDC 63323-276-01, A CONVENTIONALLY MANUFACTURED HEPARIN SODIUM (B)(4) UNITS/2 ML ((B)(4) UNITS/ML). THE DF REQUEST IDENTIFIED THE HEPARIN SOLUTION AS NDC 63323-276-01 WHICH WAS THE SAME AS THE NDC NOTED ON THE DF BARCODE SHEET. HOWEVER, THE APEX COMPOUNDING SYSTEMS USES NDCS TO IDENTIFY SOLUTIONS AND DETERMINE DFS. WITHOUT A UNIQUE NDC, THE APEX SYSTEM WOULD NOT BE ABLE TO DISTINGUISH BETWEEN CONCENTRATED CONVENTIONALLY MANUFACTURED SOLUTIONS AND THE CUSTOMER'S HEPARIN DILUTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049299 APEX® COMPOUNDER NEP B. BRAUN MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown