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Blank fields on this form indicate the information is unknown or unavailable.Procode: additional product codes: lje, gbo customer (person): phone: (b)(6).Occupation: (b)(6).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, 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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Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation on 09sep2022, our european shared service center (essc) received a complaint from dr.(b)(6), a representative at (b)(6) facility, located in the city of (b)(6).Upon placement of an ultrathane mac-loc locking loop biliary drainage catheter (rpn: ult10.2-38-40-p-32s-clb-rh, lot: 14462261), it was discovered to be leaking at the transition from the drain to the hub.A new device was used to complete the procedure.The patient did not experience any adverse effects due to this occurrence.Reviews of the documentation, including the complaint history, device history record, instructions for use (ifu), quality control procedures, as well of a visual inspection and functional test of the returned device, were conducted during the investigation.One opened ult10.2-38-40-p-32s-clb-rh was returned for evaluation in a used and damaged condition.A functional test of the device confirmed leakage from the hub of the catheter.A further examination discovered a crack within the mac-loc body cavity; however, this crack did not extend into the threads 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 in place to prevent the release of nonconforming product related to the reported failure mode.A review of the device history record (dhr) for lot 14462261, subassembly lot sa14354369 and raw material lot 2195612.2, found no relevant nonconformances that could have contributed to the failure.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_multi_rev5, 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 the dmr, ifu, dhr, design history file, and returned device, suggests that the device was not manufactured out of specification, and that there are no 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 component failure without any design or manufacturing issue likely led to the reported event.The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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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