BEUDAMED
    FDA Adverse Event Other Summary report: N

    NIPRO DISPOSABLE SYRINGE

    MDR report key: 2700427 · Received March 6, 2006

    Report

    Report Number
    1056186-2006-00002
    Event Type
    Other
    Date Received
    March 6, 2006
    Date of Event
    January 18, 2006
    Report Date
    February 8, 2006
    Manufacturer
    NIPRO MEDICAL CORPORATION
    Product Code
    FMF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE COMPLAINT, A PRODUCTION TRACING WAS COMMENCED. THE SUBJECT LOT CONTAINED 996,300 PIECES SYRINGE (WITH AND WITHOUT) NEEDLE. NO ABNORMALITIES WERE FOUND DURING REVIEW OF ALL IN-PROCESS RECORDS. CURRENTLY, SPRAY, AIR BUBBLE, AND STRETCH TRACE ON THE INSIDE WALL AND BURR ARE INSPECTED. THESE IN-PROCESS INSPECTIONS WILL BE STRENGTHENED. EVAL OF ACTUAL SAMPLE INVOLVED IN INCIDENT IS ONGOING.

    Description of Event or Problem · 1

    PT WAS STARTED ON HEMODIALYSIS WITH SYRINGES IN HEPARIN INFUSION PUMP. NOTED BLOOD BACKING UP INTO THE SYRINGE AND BLOOD DRIPPING FROM SYRINGE TO BASE OF MACHINE. PT NOTED THAT THIS WAS RELATED TO A CRACK IN THE SYRINGE BARREL. IT IS ESTIMATED THAT THERE WAS 10-15 CC OF BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIPRO DISPOSABLE SYRINGE DISPOSABLE SYRINGE FMF NIPRO MEDICAL CORPORATION JD + 10L 20050821

    Patients

    Seq Age Sex Outcome Treatment
    1 Other