BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUREFLO INJECTION PLUG

    MDR report key: 36139 · Received August 28, 1996

    Report

    Report Number
    MW1009819
    Event Type
    Malfunction
    Date Received
    August 28, 1996
    Date of Event
    June 27, 1996
    Report Date
    August 15, 1996
    Manufacturer
    TERUMO MEDICAL CORP.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PHONE CALL FROM PT; CAP LEAKING. PT WAS VISITED. FOUND CAP LEAKING WHERE WHITE PART OF CAP MEETS CLEAR PART OF CAP. CAP CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUREFLO INJECTION PLUG HEPARIN LOCK FOZ TERUMO MEDICAL CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other