The patient experienced swelling and a fever after the removal of an intravascular catheter that was used to do an intravascular drug study.A bd connect a white 360deg stopcock was used in association with the iv catheter.The patient diagnosed with thrombophlebitis, hospitalized on (b)(6) 2014, and received medications as part of the treatment plan.Following the hospitalization and treatment, the patient was discharged to home on (b)(6) 2014.
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Results: at this time a sample has not been received for evaluation.It was reported that this device may coincided with either lot number 3275151, 3245300, or 3245304.A review of the device history records revealed no irregularities during the manufacture of reported lot numbers 327515, 3245300, and 3245304.Sterilization records were also reviewed for the above lot numbers and no irregularities were noted.Conclusion: without a sample, a root cause for this incident could not be identified.Pir#: (b)(4).
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