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Blank fields on this form indicate the information is unknown or unavailable.D2a- additional common names: gbo catheter, nephrostomy, general & plastic surgery; lje catheter, nephrostomy.D2b- additional product codes: gbo; lje.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 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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Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation: on 03jul2024, it was reported that the hub of an 'ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter' was found to be leaking prior to use.The procedure was completed by using another new device.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, instructions for use as well as visual inspection and functional test of the returned product, were conducted during the investigation.The ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was returned in an opened and prepped condition.The cap/mac-loc adapter connection site passed the required gap gauge requirement.During tabletop testing, a leak test confirmed fluid escaping at the cap/mac-loc adaptor connection site.The investigation discovered a flap to be present when looking down the lumen of the mac-loc adaptor.Based on this discovery, it was determined the device was manufactured out of specification.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 nonconforming 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 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.Evidence gathered upon review of returned device suggests that the device was manufactured out of specification.However, review of the dmr and dhr suggests that there are no additional nonconforming devices in house or out in the field.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that a manufacturing and quality control deficiency contributed to the 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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