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D2a - additional common name: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy.D2b - additional product code: gbo, lje.E1 - customer (person): postal code: (b)(6), phone (b)(6).G4 - pma/510(k) #: k173035.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.It was reported that leakage was identified at the hub of an ultrathane mac-loc locking loop multipurpose drainage catheter during an unknown procedure.A new like-device was opened to complete the procedure successfully.The patient did not experience any adverse effects or require additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), quality control procedures, and specifications, as well as a visual inspection, functional test, and dimensional verification of the returned device, were conducted during the investigation.One used ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was received.The investigation confirmed the white cap / mac-loc adapter connection site passed the gap gauge requirement.During tabletop testing, a leak test confirmed fluid escaping from the cap / mac-loc adaptor connection site.A visual examination discovered the flare folded over the opening within lumen of the mac-loc adaptor.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 confirmed there were no relevant recorded nonconformances.To date, a further search of our database records revealed no additional complaints associated with the reported lot.The information provided upon review of the dhr and device evaluation suggests that the device was manufactured out of specification, and that there is evidence of additional nonconforming product in the field.Containment was performed on the complaint lot.Additionally, a nonconformance investigation and a supplier corrective action request were initiated due to this occurrence.Any request to assess for field action will be addressed in the nonconformance investigation.Cook also reviewed product labeling.The instructions for use (ifu) [ t_multi2 rev1, multipurpose drainage catheter] states the following.How supplied: "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, inspection of the returned device, and the results of the investigation, cook medical has concluded that the main cause of failure is manufacturing related.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.
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