BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M CUROS JET DISINFECTING CAP FOR NEEDLELESS CONNECTORS

    MDR report key: 6518601 · Received April 25, 2017

    Report

    Report Number
    2110898-2017-00053
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Date of Event
    January 1, 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. CUSTOMER REPORTED THE EVENT OCCURRED IN EARLY (B)(6) AND DID NOT HAVE THE EXACT DATE OF THE EVENT. ON (B)(6) 2017 WAS USED FOR DATE OF EVENT IN THIS REPORT. ON 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 2110898-2017-00053 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 NEEDLELSS CONNECTORS. A NURSE CLAMPED THE IV TUBING BELOW THE NEEDLELESS CONNECTOR AND THE INFUSION PUMP DID NOT RECOGNIZE A DOWNSTREAM OCCLUSION BECAUSE IT WAS LEAKING UNDER THE CUROS JET CAP. DURING A ROUTINE ASSESSMENT, THE PATIENT REPORTED A FEW DROPS OF FLUID FROM THE NEEDLELESS CONNECTOR/ CUROS JET CAP CONNECTION HAD DRIPPED ONTO HER PAJAMAS. THE CUROS JET CAP WAS REMOVED AND REPLACED WITH A NEW ONE. NO FURTHER LEAKING WAS NOTED ON THAT SHIFT. CUSTOMER REPORTED NO HARM OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301252 3M CUROS JET DISINFECTING CAP FOR NEEDLELESS CONNECTORS CUROS JET DISINFECTING CAP LKB 3M HEALTH CARE

    Patients

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