BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTRIDGE RG MEDICATION 3ML

    MDR report key: 17509006 · Received August 10, 2023

    Report

    Report Number
    MW5122900
    Event Type
    Injury
    Date Received
    August 10, 2023
    Report Date
    August 7, 2023
    Manufacturer
    CHENGDU SHIFENG MEDICAL TECHNOLOGY CO., LT.
    Product Code
    MRZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PT REPORTS THEIR INFUSION SITE IS VERY SWOLLEN, RED, AND PAINFUL WHEN THEY MOVE AROUND, WHICH IS OUT OF THE ORDINARY FOR THEM. PT IS REQUESTING LIDOCAINE/PRILOCAINE CREAM AND TRIAMCINOLONE CREAM; PT DOES NOT USE PLO-GEL. PT IS AGREE, ABLE TO POTENTIAL OUTREACH BY CNSS FOR EVALUATION. SQ SITE WAS PLACED (B)(6) 2023, PT ALSO REPORTS THE CARTRIDGES DISPENSED SPECIFICALLY FOR SQ TREPROSTINIL MS3 TEND TO BE LOOSE FITTING AND THEY HAVE WASTED MEDICATION ON AT LEAST 4 OCCURRENCES (DATE UNKNOWN). PT PROVIDED CARTRIDGE LOT NUMBER 220908, BUT CONFIRMED THIS ISSUE HAS OCCURRED WITH SEVERAL DIFFERENT DISPENSES. PT STATES THEY HAD EXISTING SUPPLY OF CARTRIDGES SPECIFIC TO REMODULIN DISPENSING THAT THEY USED TO CONTINUE SQ TREPROSTINIL INFUSION WITHOUT PROBLEMS. NO INTERRUPTION TO THERAPY OR ILL-EFFECTS REPORTED. UNKNOWN IF MD AWARE. NO FURTHER INFO, DETAILS OR DATES AVAILABLE. REF REPORTS: MW5122898, MW5122899, MW5122901. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050062 CARTRIDGE RG MEDICATION 3ML ACCESSORIES, PUMP, INFUSION MRZ CHENGDU SHIFENG MEDICAL TECHNOLOGY CO., LT.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female