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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): line 2: (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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Investigation ¿ evaluation it was reported that an ultrathane mac-loc locking loop multipurpose drainage catheter package was found to be unsealed prior to the use of drainage catheter.A new like device was used to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The photo provided by the customer confirms open package seals without evidence of adhesive.Reviews of the documentation, including the complaint history, device history record, quality control procedures, manufacturing instructions and instructions for use (ifu), as well as a visual inspection of the returned device, were conducted during the investigation.The ultrathane dawson-mueller mac-loc locking loop multipurpose drainage catheter was returned in unused condition.A visual examination of the package confirmed there is no evidence of adhesive transfer from the pe/pet to the tyvek backing.The lack of adhesive transfer to the tyvek backing confirms the pouch was not sealed during the packaging process.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 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: instructions for use (ifu) document t_multi2 rev1 [multipurpose drainage catheter] is packaged with this device.No sections relevant to the failure mode were noted.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/quality control 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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