BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVISION-PLUS

    MDR report key: 6285515 · Received January 25, 2017

    Report

    Report Number
    MW5067534
    Event Type
    Malfunction
    Date Received
    January 25, 2017
    Date of Event
    January 23, 2017
    Report Date
    January 23, 2017
    Manufacturer
    RY-MED TECHNOLOGIES LLC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT SHE NOTICED THAT HER LINE WAS LEAKING AND REALIZED THAT THE INVISION-PLUS CONNECTOR WAS CRACKED AND IT WAS LEAKING FROM THERE. PATIENT PUT THIS CONNECTOR ON THE LINE A WEEK AGO SO SHE DOES NOT HAVE THE LOT NUMBER. SHE DID SAVE THE CONNECTOR AND WILL SEND IT BACK TO US. SHE CHANGED THE CONNECTOR AND HAS NOT HAD ANY PROBLEMS WITH HER BREATHING OR OTHER SYMPTOMS. THE PRODUCT NUMBER IS RYM-5000 MADE BY RYMED TECHNOLOGIES, LLC INVISION-PLUS. DATES OF USE: (B)(6) 2016 TO CURRENT. DIAGNOSIS OR REASON FOR USE: PAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60539 INVISION-PLUS CONNECTOR FPA RY-MED TECHNOLOGIES LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR DOSE OR AMOUNT: VELETRI 22NKM, | FREQUENCY: CONTINUOUS, ROUTE: IV.