Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation evaluation.It was reported that a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set (c-utlm-701j-rsc-abrm-hc-rd) from lot 9486871 became occluded a week after placement in the right subclavian vein.All lumens were flushed and unused lumens were filled with saline prior to introduction.Cook became aware of this event on (b)(6) 2020 upon being notified by (b)(6) hospital.The patient reportedly experienced no adverse effects as a result of this incident.A review of documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions and quality control, as well as a visual inspection and functional test of the returned device was conducted during the investigation.One used triple lumen central venous catheter was returned for evaluation.The distal tip of the catheter has been cut off.A cook microclave was returned attached to the blue hub.Two third party microclaves were attached to the red and white hubs.Sticky residue was noted on the catheter and manifold.The red and blue lumens were able to be flushed with no issue.Some resistance was felt when flushing the white lumen until biological matter was flushed out.Upon flushing out residual biological matter, resistance was no longer felt when flushing.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record for lot 9486871 found no nonconformances that could have contributed to the failure mode.Catheter subassembly lot ic 9322767 revealed three related nonconformances, in which one device was scrapped due for out of round side ports and three devices were scrapped due to abrm coating in the inner diameter.It should be noted that there were no other complaints reported for lot 9486871.There is no evidence to suggest that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: suggested catheter maintenance to prevent clotting or possibility of air embolus, the double-lumen¿s #2 lumen, the triple-lumen¿s #2 and #2 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.Any unused lumens should be maintained with continuous saline or heparinized saline drip or locked with heparinized saline solution.Before using any lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumens should be flushed with normal saline between administrations of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin lock.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that the patient condition potentially contributed to the event.It is likely that biological matter, like what was flushed from the returned device, formed the reported occlusion.The obstruction may have formed since regular saline was used to lock.The customer stated that heparinized saline could not be used since the patient had brain surgery.The ifu recommends that unused lumens be maintained with a heparinized saline lock, not a regular one.If heparinized saline was used, the occlusion could have been prevented.The appropriate personnel have been notified.Per the quality engineering 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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