BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD SAF-T-INTIMA

    MDR report key: 1837696 · Received September 10, 2010

    Report

    Report Number
    9610847-2010-00040
    Event Type
    Death
    Date Received
    September 10, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 11, 2010
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: AFTER RECEIVED AND INSPECTED THE SAMPLE, WE CONFIRMED THE DEFECT IN THE SAMPLE: LEAKAGE ON TUBING. NOTE: THE CUSTOMER STATES: THE NURSE FOUND BLOOD LEAKAGE FROM THE CATHETER NEAR TO THE WING DURING THE REMOVAL OF THE STYLET. DURING THE LEAK TEST, TWO DIFFERENT POSITION OF DAMAGE (KINKED) WERE NOTED THROUGH THE TUBE, ONE NEAR THE WING AND ONE NEAR TO THE ADAPTER. CONCLUSIONS: WE CAN'T DETERMINE IF THE FAILURE IS RELATED TO THE MANUFACTURING PROCESS OR WAS CAUSED DURING USE. THERE IS A POSSIBILITY THAT DURING RETRACTION OF THE STYLET, THE TUBING MAY HAVE GOTTEN DAMAGED ACCIDENTALLY (BY THE NEEDLE) IF THE OPERATION WAS CONDUCTED INCORRECTLY PER THE IFU (INSTRUCTIONS FOR USE). CORRECTIVE ACTION: NO CORRECTIVE ACTION WILL BE GENERATED AS THIS INCIDENT IS NOT RELATED WITH THE MANUFACTURING PROCESS. (B)(4).

    Description of Event or Problem · 1

    THE NURSE FOUND BLOOD LEAKAGE FROM THE CATHETER NEAR THE WING DURING REMOVING THE STYLET. ON (B)(6) 2010, BD (B)(6) RECEIVED AN EMAIL COMMUNICATION FROM BD (B)(4) INDICATING THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD SAF-T-INTIMA INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| R