Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation.A representative from ochsner lsu health (usa) reported that on (b)(6) 2023, an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-25-p-6s-clm-rh; lot#: 15190756) separated.The catheter was placed in an unknown patient on (b)(6) 2023 for drainage of an abdominal fluid collection in the gallbladder fossa.After the patient was discharged to home, the mac-loc hub separated from the catheter.The patient returned to the hospital on (b)(6) r2023 to have the device removed and replaced.No other adverse effects were reported due to this occurrence.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that inspection activities are currently in place to prevent the release of nonconforming product related to the reported failure mode.A review of the device history record (dhr) for lot 15190756 found one relevant nonconformance, in which all affected devices were scrapped prior to further processing.It should be noted that there are no other complaints associated with the final product lot number.Cook also reviewed product labeling.The ifu supplied (t_multi2_rev1, ultrathane mac-loc locking loop biliary drainage catheter) instruct that the product should be inspected prior to use to ensure no damage has occurred.Evidence gathered upon review of the dmr, dhr and ifu suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, no returned product, and the results of our investigation, a definitive cause for the failure could not be established.It is possible that the catheter underwent excessive force or tension at his/her residence, but this cannot be confirmed.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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