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B3 - date of event: date of event is between 15nov2024 to 21nov2024 d2a - common device name: additional names: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy.D2b - product code: additional product codes: gbo, lje.E1- customer (person): (b)(6).E3 - occupation: nurse unit manager.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 unknown, unchanged or unavailable.Investigation ¿ evaluation it was reported that an ultrathane mac-loc locking loop multipurpose drainage catheter leaked at the hub when locked.The leakage was not discovered when flushing prior to use.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the documentation, including the complaint history, device history record, quality control procedures and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.Only one of the two reported devices was returned.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 the lumen of the mac-loc adaptor.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that inspection activities are currently in place to prevent the release of non-conforming product related to the reported failure mode.A review of the device history record (dhr) for the device found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling: the current instructions for use [ifu_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." precautions patients with indwelling drainage catheters should be evaluated routinely to ensure continuous function of the catheter.Evidence gathered upon review of the dmr, ifu, dhr, and the device evaluation suggests that the device was manufactured out of specification.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that a manufacturing deficiency contributed to the reported event.Per the risk assessment no further action is required.The appropriate personnel have been notified.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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