|
(b)(6).Pma/510(k) #: exempt.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, 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.
|
|
It was reported the catheter in an ultrathane multipurpose drainage set leaked.The device was required for abscess drainage and was placed in the patient by right hepatic duct approach.During the procedure, when the physician attempted to remove air, air entered from the connection between the hub and catheter.As a result, a new, like device was obtained to successfully complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
|
|
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation on (b)(6) 2022, cook japan received a complaint from a representative at the (b)(6) facility reporting the catheter in an ultrathane multipurpose drainage set (rpn cldm-8.5-mh, lot 14163347) leaked.The device was required for abscess drainage and was placed in the patient by right hepatic duct approach.During the procedure, when the physician attempted to remove air, air entered from the connection between the hub and catheter.As a result, a new, like device was obtained to successfully complete the procedure.The patient did not experience any adverse effects or require any additional procedures.A review of complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures were 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.A review of the device master record (dmr) concluded 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 14163347 and subassembly mac-loc lots sa14011626 and sa14072844 revealed no relevant non-conformances or additional complaints.The torque driver used in manufacturing was within calibration.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed the product labeling for the complaint device.The instructions for use (ifu) [ t_multi2_rev1], multipurpose drainage catheter] packaged with the device contains the following in relation to the reported failure mode: how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, no returned device, and the results of the investigation, cook concluded the root cause category would fall under cause traced to component failure, being defined as component failure without any design or manufacturing issue.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.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.
|
