BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV CONNECT INV PLUS TOUCH S

    MDR report key: 14986584 · Received July 11, 2022

    Report

    Report Number
    MW5110788
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Report Date
    July 6, 2022
    Manufacturer
    RYMED TECHNOLOGIES, LLC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SOLICITED CALL TO PATIENT WHO REPORTED THAT HER IV CONNECT IS STUCK AND SHE HAS NOT BEEN ABLE TO CHANGE IT FOR ABOUT 1.5 MONTHS. UNKNOWN IF HER DOCTOR IS AWARE. PATIENT DID NOT REPORT ANY SIDE EFFECTS OR CHANGES IN BREATHING. PATIENT DID NOT PROVIDE A LOT NUMBER FOR THE ITEM. UNKNOWN IF PATIENT MISSED A DOSE. UNKNOWN IF PRODUCT ON HAND FOR RETURN. NO OTHER INFORMATION PROVIDED. REPORTED TO CVS/CAREMARK BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637878 IV CONNECT INV PLUS TOUCH S SET, ADMINISTRATION, INTRAVASCULAR FPA RYMED TECHNOLOGIES, LLC RYM-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Female