BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOUS BLOODLINE NON-MACHINE SPECIFIC

    MDR report key: 278162 · Received May 10, 2000

    Report

    Report Number
    8030665-2000-00139
    Event Type
    Injury
    Date Received
    May 10, 2000
    Date of Event
    March 18, 2000
    Report Date
    April 17, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLINIC REPORTS THAT DURING TREATMENT THE VENOUS LINE PT CONNECTOR TO THE QUINTON PERM CATH LOOSENED RESULTING IN A PT BLOODLOSS OF 100CC. THE PT HAD A LOW HEMATOCRIT (10.6) AND WAS GIVEN A UNIT OF PACKED RED BLOOD CELLS. NO SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE NON-MACHINE SPECIFIC BLOODLINE FKJ ERIKA DE REYNOSA NA 9LR086

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other| R