BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUROS

    MDR report key: 9025438 · Received September 13, 2019

    Report

    Report Number
    9025438
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Date of Event
    August 15, 2019
    Report Date
    August 15, 2019
    Manufacturer
    3M COMPANY
    Product Code
    QBP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    CUROS CAP WAS BEING CHANGED AND IT BROKE OFF AT THE RIM. THIS IS A PATIENT SAFETY ISSUE AS IT COULD CAUSE A CENTRAL LINE ASSOCIATED BLOODSTREAM INFECTION. MANUFACTURER RESPONSE FOR CUROS CAP FOR MALE LUER, CUROS CAP (PER SITE REPORTER). FOLLOW-UP UNKNOWN RESPONSE UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    CUROS CAP WAS BEING CHANGED AND IT BROKE OFF AT THE RIM. THIS IS A PATIENT SAFETY ISSUE AS IT COULD CAUSE A CENTRAL LINE ASSOCIATED BLOODSTREAM INFECTION. MANUFACTURER RESPONSE FOR CUROS CAP FOR MALE LUER, CUROS CAP (PER SITE REPORTER). FOLLOW-UP UNKNOWN RESPONSE UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812792 CUROS CAP, DEVICE DISINFECTANT QBP 3M COMPANY 6525317

    Patients

    Seq Age Sex Outcome Treatment
    1