BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INF SET CLEO 31" 9MM

    MDR report key: 13479735 · Received February 7, 2022

    Report

    Report Number
    MW5107269
    Event Type
    Injury
    Date Received
    February 7, 2022
    Date of Event
    January 1, 2022
    Report Date
    February 1, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FPA
    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

    CAREGIVER REPORTED THAT SHE WENT TO PLACE PATIENTS DEO AND THE NEEDLE LOOKED A LITTLE DIFFERENT THAN THEY WERE USED TO. WHEN SHE WENT TO PLACE CLEO, PATIENT SCREAMED IN PAIN AND THERE WAS BLOOD. CAREGIVER DID NOT HAVE PACKAGING FROM THAT SET. AUTHOR EXPRESSED CONCERN THAT IT WAS NOT A DEO SINCE SHE SAID IT LOOKED DIFFERENT. AUTHOR ADVISED CAREGIVER TO NOT USE ANY PRODUCTS THAT LOOK DIFFERENT FROM WHAT THEY ARE USED TO AND TO CONTACT PHARMACY FIRST. NO OTHER INFORMATION AVAILABLE. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757324 INF SET CLEO 31" 9MM SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female