A sample is not available for evaluation, however the customer returned photos for analysis.A photo inspection revealed a broken catheter with a slight deformity at its tip.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6947150.A manufacturing review revealed no related issues during production.Although the photos confirmed the customer's indicated failure mode, without a sample an absolute root cause for this incident cannot be determined.Additionally, our quality engineer notes that the reported failure most likely was caused by the patient while dragging his/her hand on the bedding and knocking his/her hand against a table.(b)(4).
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