BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARATA PASS SOFTWARE

    MDR report key: 19404911 · Received May 24, 2024

    Report

    Report Number
    MW5155401
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Report Date
    May 24, 2024
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    OUG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS DISCOVERED WHILE CHECKING CPMP POUCHES THAT THE DESCRIPTION OF TRAZODONE 100MG TABLETS NDC 13668-0331-05 HAD AN INCORRECT DESCRIPTION ON THE MED PACK POUCH BAGS. IT WAS LABELED AS A ROUND OVAL TAB WITH MARKINGS 07 08 BUT SHOULD HAVE SAID ROUND WHITE TAB 13 31. WRONG DESCRIPTION WAS BEING PRINTED ON INDIVIDUAL MED PACK BAGS WHEN TRAZODONE 100MG WAS BEING DISPENSED. TABLET AND CAPSULE DESCRIPTIONS ARE ENTERED IN THE PARATA PASS SOFTWARE DATABASE MANUALLY WHEN STAFF ADD A NEW NDC; THIS NDC WAS ADDED MANY MONTHS AGO IN XXXXXXXX 2023. UNSURE WHERE THE DESCRIPTION "ROUND, OVAL 07 08" CAME FROM. USUAL PRACTICE IS TO USE THE DESCRIPTION IN RX30 DRUG RECORDS. ERROR WENT UNDETECTED FOR MONTHS BEFORE STAFF IDENTIFIED IT. NO REPORTS OF IT CAUSING CONFUSION FOR PATIENTS. ERROR WENT UNDETECTED FOR MONTHS BEFORE STAFF IDENTIFIED IT. NO REPORTS OF IT CAUSING CONFUSION FOR PATIENTS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940035 PARATA PASS SOFTWARE MEDICAL DEVICE DATA SYSTEM OUG BECTON, DICKINSON & CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TRAZODONE HCL.