BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAY, PORT-A-CATH ACCESS

    MDR report key: 7534159 · Received May 21, 2018

    Report

    Report Number
    MW5077382
    Event Type
    Malfunction
    Date Received
    May 21, 2018
    Date of Event
    May 9, 2018
    Report Date
    May 17, 2018
    Manufacturer
    MEDLINE INDUSTRIES INC.
    Product Code
    OKE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHEN THE PORT-A-CATH ACCESS KIT WAS OPENED, THERE WAS NO CHLORHEXIDINE SCRUB OR STERILE FLUSH. THIS KIT WAS INCOMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372156 TRAY, PORT-A-CATH ACCESS PORT INTRODUCER KIT OKE MEDLINE INDUSTRIES INC. 179B0431

    Patients

    Seq Age Sex Outcome Treatment
    1