It was reported that a (b)(6) male patient was hospitalized for appendicitis, pneumonia, and benign prostatic hyperplasia.A bd pegasus safety closed iv catheter system was placed in the patient.Before surgery but after an infusion (the iv catheter placement time is not clear), the patient developed a high fever.Blood cultures were collected from the patient, tested positive, and the patient was treated with antibiotics.Of note, it was also reported that the hospital where the incident occurred conducted an investigation and confirmed that the iv catheter reported was not the cause of the reported fever.
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One unused and sealed sample was returned for evaluation.A visual/microscopic inspection revealed no irregularities and an endotoxin inspection met requirements (20 eu/device).A review of the device history record, incoming/outgoing inspection, packaging, and sterility record revealed no irregularities during the manufacture and sterilization of the reported lot # 5169315.Conclusion: an absolute root cause for this incident cannot be determined.Additionally, our quality engineer notes that the incident is not related to the manufacturing process of the device.
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