BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAVASCULAR CATHETER

    MDR report key: 322161 · Received March 21, 2001

    Report

    Report Number
    2523676-2001-00006
    Event Type
    Injury
    Date Received
    March 21, 2001
    Date of Event
    January 16, 2001
    Report Date
    February 26, 2001
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    FMI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    INFO RECEIVED FROM A MEDWATCH STATES: "WHILE THE PHYSICIAN WAS REFILLING AN IMPLANTED ARROW PUMP RESERVOIR WITH HEPARIN - 50,000 UNITS - IN BACTERIOSTATIC WATER - Q TO 30ML -, THE NEEDLE BROKE OFF AT THE BASE WHILE STILL INSERTED IN THE PT. THE PHYSICIAN REMOVED THE NEEDLE WITH AN ALCOHOL PAD AND CLAMP. THE NEEDLE WAS BENT ABOUT 30 DEGREES APPROX 3/4 INCHES FROM THE BASE DURING THE REMOVAL PROCESS. PACKAGED NEEDLE IS STRAIGHT." THE SAMPLE AND ADDITIONAL INFO (AGE, SEX, WEIGHT) WERE RECEIVED 3/14/2001. THE PT SUFFERED NO ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12533 INTRAVASCULAR CATHETER 22GA. X 1-1/2" HUBER NEEDLE FMI B. BRAUN MEDICAL, INC. H-2215 60032074

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention