BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROBOTIC SYRINGE AND BAG FILLING AND LABELING SYSTEM

    MDR report key: 14488786 · Received May 23, 2022

    Report

    Report Number
    MW5109889
    Event Type
    Injury
    Date Received
    May 23, 2022
    Date of Event
    May 19, 2022
    Report Date
    May 19, 2022
    Manufacturer
    UNK
    Product Code
    NEP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IV ROBOT - SMARTFILLER FROM CARGIN, LLC IN OPERATION SINCE 2018 FILLS IV SYRINGES FOR PATIENT USE. OVER THE COURSE OF 4 YEARS, THE ROBOT HAS CREATED MANY NEAR-MISS SITUATIONS THAT COULD POTENTIALLY COMPROMISE PATIENT SAFETY. THE DEVICE HAS THE POTENTIAL TO UNDER FILL SYRINGES, PACKAGE AND LABEL SYRINGES WITHOUT ANY MEDICATIONS ADDED. HAS HAPPENED ON MULTIPLE OCCASIONS. OTHER ISSUES INCLUDE SYRINGES LABELED WITH INCORRECT BARCODE, INCORRECT BEYOND USE DATES, AND DRUG NAME ALL ERRORS WHICH HAVE BEEN CAUGHT PRIOR TO PATIENT DISTRIBUTION. VENDOR HAS BEEN UNCOOPERATIVE WITH RESOLUTION. CARGIN LLC, (B)(4) US. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2192717 ROBOTIC SYRINGE AND BAG FILLING AND LABELING SYSTEM SYSTEM/DEVICE, PHARMACY COMPOUNDING NEP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| L