It was reported the ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter leaked following a right sided pleurocentesis procedure of a 70 year-old, female patient.After drain had been in place for an unknown amount of time, the catheter was noted to be leaking just proximal to the mac-loc and not draining well.They also noted what looked like air in the drainage bag.The catheter was removed immediately.A chest x-ray was performed and a pneumothorax was diagnosed.An additional procedure was required to replace the drain, and pneumothorax care and monitoring for the patient was performed.No other adverse effects have been reported for this incident.
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Correction: report reference information - date aware.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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 or that a death or serious injury occurred; nor is it admission 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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On (b)(6) 2023, (b)(6) reported an issue with an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter (ult8.5-38-25-p-5s-cldm-hc) from lot 15129359.Immediately after placement in the pleura to treat a right pleural effusion, the drain was noted to be leaking.Air was observed in the drainage bag, and the drain was immediately removed.Chest radiography confirmed a new pneumothorax.The patient received a new drain and pneumothorax monitoring/care was administered.No other adverse effects were reported.Reviews of the complaint history, device history record (dhr), quality control, specifications, and instructions for use (ifu), as well as a visual inspection, functional test, and dimensional verification of returned product, were conducted during the investigation.The complainant returned one used catheter as well as six sealed, unused devices from the same lot to cook for investigation of events with patient identifiers (b)(6) (mdr# 1820334-2023-00837), (b)(6) (mdr# 1820334-2023-00838), and (b)(6) (mdr# 1820334-2023-00841).It¿s unknown which event the used device is from, but it will be attributed to patient identifier (b)(6) (mdr# 1820334-2023-00837) for documentation purposes.The used device leaked during functional testing.The distance between the cap and mac-loc assembly was measured and was determined to be within specification.Visual inspection found the flare folded inward inside the hub.Based on the folded flare, the used device was determined to be out of specification.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 dhrs for the reported complaint device lot and the related subassembly lots revealed one related non-conformance for ¿flare inadequate - stiffener exited out cap¿ in which seven devices were scrapped.A database search identified two other events reported for the same failure mode, from the same customer.The catheter is supplied to cook.Additional lots manufactured by the same personnel as the complaint lot were reviewed.Further investigation of these lots found potentially related nonconformances, but no additional complaints from the field.Based on the available information, cook has concluded that that there are possible nonconforming devices in the field.Containment was performed on related lots, but field action was determined not to be necessary.Cook also reviewed product labeling.Instructions for use (ifu) document t_multi2_rev1 is packaged with this device.The product ifu states the following in consideration of the reported failure mode: ¿how supplied: upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, inspection of returned devices, and the results of the investigation, cook has concluded a manufacturing deficiency at the supplier contributed to this incident.The appropriate personnel have been notified.Per the risk assessment no further action is required.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 or that a death or serious injury occurred; nor is it admission 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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