BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RYM-5001

    MDR report key: 1037574 · Received May 1, 2008

    Report

    Report Number
    MW5006534
    Event Type
    Malfunction
    Date Received
    May 1, 2008
    Date of Event
    April 16, 2008
    Report Date
    May 1, 2008
    Manufacturer
    RYMED TECHNOLOGIES, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2008, RESPONSE FROM RYMED INDICATED THAT THERE WAS A INJECTION CAP/CURLIN PUMP TUBING INCOMPATIBILITY. USING THE TWO PRODUCTS TOGETHER CAUSED THE SEPTUM OF THE RYMED INJECTION CAP TO PERFORATE AND LEAK. A WEEK LATER, I REPORTED TUBING/SUPPLY INCOMPATIBILITY OCCURRENCES USING THE CURLIN PUMP TUBING AND THE RYMED INVISION PLUS INJECTION CAP TO CURLIN MFG. A CORING DEFECT OCCURS IN THE SEPTUM OF THE RYMED INVISION PLUS INJECTION CAP WITH 3-4 ATTACHMENTS. THE OPENING OF THE CURLIN TUBING INNER DIAMETER IS TOO SMALL TO ACCOMMODATE THE PISTON ACTION OF THE RYMED INJECTION CAP. FOLLOWING A LIST OF THE SUPPLIES IN QUESTION: RYMED INJECTION CAP WITH EXTENSION RYM-5215, A STERILE PACKAGED INJECTION CAP RYM-5001, A FINO TOUCHFL INJECTION CAP RYM-5000, A CURLIN 1.2 MICRON FILTER - TUBING AND A CURLIN .2 MICRON FILTER - TUBING. APPROX DATES OF USE: 2006 - 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RYM-5001 FPA RYMED TECHNOLOGIES, INC.
    2 RYM-5001 FPA RYMED TECHNOLOGIES, INC
    3 RYM-5215 FPA RYMED TECHNOLOGIES, INC
    4 CURLIN PUMP TUBING FPA CURLIN MEDICAL
    5 CURLIN PUMP TUBING FPA CURLIN MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other