BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M CUROS JET DISINFECTING CAP FOR NEEDLELESS CONNECTORS

    MDR report key: 6520033 · Received April 25, 2017

    Report

    Report Number
    2110898-2017-00054
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Date of Event
    January 13, 2017
    Report Date
    April 21, 2017
    Manufacturer
    3M HEALTH CARE
    Product Code
    LKB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION NOT PROVIDED BY REPORTER. DATE OF THIS REPORT: 04/21/2017- DATE 3M MANAGEMENT MADE THE INTERNAL DECISION TO FILE AN MDR REPORT FOR THIS COMPLAINT. 3M COMPLETED A RETROSPECTIVE COMPLAINT REVIEW. THIS REPORT 2110898-2017-00054 IS NOW BEING FILED WITH THE FDA DUE TO SIMILAR REPORTS WHERE AN INJURY OCCURRED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CUROS JET CAPS WERE PLACED ON THE IV TUBING NEEDLELESS CONNECTORS. INTRALIPIDS WERE FOUND TO BE LEAKING FROM THE MIDDLE NEEDLELESS CONNECTOR/ CUROS JET CAP CONNECTION ON THE IV TUBING. PARENTERAL NUTRITION AND INTRALIPIDS WERE REPORTEDLY INFUSING VIA AN INFUSION PUMP. CUSTOMER REPORTED NO HARM TO THE PATIENT WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301701 3M CUROS JET DISINFECTING CAP FOR NEEDLELESS CONNECTORS CUROS JET DISINFECTING CAP LKB 3M HEALTH CARE 20160628-26

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BAXTER TUBING WITH CLEARLINK NEEDLELESS CONNECTORS| SIGMA LARGE VOLUME INFUSION PUMP