It was reported an unknown patient required an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter for bile duct drainage.Immediately following placement, when the physician applied negative pressure, bile leaked between the mac-lock hub and catheter.The device was removed and replaced with a similar device to complete the procedure successfully.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.(b)(6) informed cook that an ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter from lot 13482348 leaked during placement.The catheter was placed in the bile duct percutaneously.When the physician applied negative pressure right after placement, fluid leaked between the mac-lock hub and catheter.Therefore, another drainage catheter was used instead.There have been no adverse effects to the patient reported.A review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, and quality control of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.The customer returned one used 8.5fr ult catheter.There is biological matter throughout and no visible damage.A leak test confirmed leakage where the catheter enters the connector cap.The distance between the cap and the hub was measured and determined to be within specification.Additionally, a document based investigation evaluation was performed.The risk specifications covering mac-loc drainage catheters includes hub separation as a potential failure mode.The identified risk controls include the manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.Based on the review of current documentation, cook has concluded that inspection activities are currently in place to prevent the release of non-conforming product related to the reported failure mode.The ifu supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.A review of the device history record (dhr) was also conducted as a part of the investigation to check for failure related nonconformances and additional complaints.Lot 13482348 did not have related nonconformances.There are no additional complaints on this lot.There is no evidence of nonconforming material in house or in the field.There is no evidence of manufacturing deficiency, therefore, the cause of this event is component failure.The appropriate personnel have been notified.Per the quality engineering 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, 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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