BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOUS BLOODLINE FOR FRESENIUS 2008

    MDR report key: 279246 · Received May 16, 2000

    Report

    Report Number
    8030665-2000-00179
    Event Type
    Malfunction
    Date Received
    May 16, 2000
    Date of Event
    May 2, 2000
    Report Date
    May 9, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLINIC REPORTS THAT DURING THE PT'S TREATMENT THE VENOUS LINE BECAME LOOSE FROM THE MEDCOMP SPLIT ASH CATHETER AND LEAKED ABOUT 50-75CC OF BLOOD. NO ADDITIONAL PT ILL EFFECTS. THE MACHINE DID NOT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE FOR FRESENIUS 2008 BLOODLINE FKJ ERIKA DE REYNOSA NA 9SR060

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other MEDCOMP SL28C CATHETER, 2008H.