BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENOUS BLOODLINE NON-MACHINE SPECIFIC

    MDR report key: 289241 · Received August 8, 2000

    Report

    Report Number
    8030665-2000-00237
    Event Type
    Injury
    Date Received
    August 8, 2000
    Date of Event
    July 13, 2000
    Report Date
    July 14, 2000
    Manufacturer
    ERIKA DE REYNOSA
    Product Code
    FKJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    "QS" NOTIFIED BY FMC PRODUCT COMPLAINT OF THIS PT DISCONNECT. THE REPORT STATED "VENOUS LINE DISCONNECTED FROM LUER CONNECTOR PORTION". ESTIMATED BLOOD LOSS 120CC. NURSE REPORTING THE INCIDENT CALLED. FROM THE INFO RECEIVED THE INCIDENT SOUNDS MORE LIKE A SEPARATION OF THE VENOUS TUBING FROM THE CLEAR PLASTIC PART OF THE CONNECTOR. AWAITING SAMPLE AVAILABILITY. 8/8/00: SAMPLE AVAILABLE AND REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE NON-MACHINE SPECIFIC TUBING FOR HEMODIALYSIS FKJ ERIKA DE REYNOSA NA 0ER146

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other FRESENIUS 2008H.