The patient reported his ultrathane mac-loc locking loop biliary drainage catheter was leaking bile from the hub connector of the catheter after a routine drainage tube exchange.Per the patient, it appeared the connection hub had unscrewed/come away from the catheter.As a result, the patient returned to the facility and the device was replaced with another one.No other adverse events were reported for this incident.Additional information regarding patient information and event details have been requested but are unavailable at this time.
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Investigation ¿ evaluation.A review of the documentation of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be established.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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