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Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation: it was reported that the white port of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set was found to be occluded during placement in a 63-year-old male patient.The physician then removed the complaint device from the patient and replaced it with a new like-device.The lumens were filled with saline solution prior to catheter introduction.The lumens were able to be flushed successfully prior to placement.The unused lumens were maintained by being locked with heparinized saline solution.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the documentation, including the complaint history, device history record, quality control procedures, manufacturing instructions, specifications and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.Cook received one used catheter from the customer.Table top testing was confirmed occlusion the white hub lumen.An ultrasound bath was unable to clear the lumen.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for the device lot and related subassembly lots found no relevant nonconformance that could have contributed to the reported failure.It should be noted that there was one other complaint associated with the final product lot number.Cook also reviewed product labeling: the product ifu, [c_t_ctulmabrm_rev7] ¿cook spectrum central venous catheter minocycline/rifampin antibiotic impregnated power injectable,¿ provides the following information to the user related to the reported failure mode: warnings: ¿failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.¿ clincal studies: product recommendations.Suggested catheter maintenance: ¿to prevent clotting or possibility of air embolus, the double-lumen¿s #2 lumen, the triple-lumen¿s #2 and #3 lumens and the five-lumen¿s #2, #3, #4, and #5 lumens should be filled with saline solution or heparinized saline solution (100 units of heparin per ml of saline is usually adequate), depending on institutional protocol, prior to catheter introduction.¿ instructions for use: ¿2.Prepare the catheter for insertion by flushing each of the lumens and clamping or attaching the injection caps to the appropriate extensions.¿9.-lumens should now be flushed with 5-10ml normal saline prior to use or establishment of heparin lock.¿ evidence gathered upon review of dmr, product labeling, dhr and device failure analysis, does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that a component failure unrelated to manufacturing deficiencies contributed to the reported event.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook 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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