Blank fields on this form indicate the information is unknown, unchanged, or unavailable.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: as reported, on 27jan2021 by (b)(6) hospital, canada, an unknown patient required the placement of an ultrathane mac-loc locking loop multipurpose drainage catheter (rpn: ult8.5-38-45-p-6s-clm-rh, product lot number: 9992705) during a nephrostomy drainage tube exchange.The operator reported during the case they attempted to use three catheters.Each catheter failed as, the ¿stiffener wouldn¿t insert into the tube.¿ one of the catheters was able to have the flexible stiffener inserted, however the stiffener broke off inside the catheter.The radiologist had to work with various guidewires to retrieve the catheter before using another similar device to complete the procedure.No adverse effects to the patient were reported.A review of the documentation including the complaint history, device history record, instructions for use (ifu) and quality control procedures, as well as a visual inspection and functional test of the returned unused product was conducted during the investigation.Five sealed devices were returned for evaluation.No visible damaged was noted to the devices upon visual inspection.The metal cannula and blunt stylets were inserted and removed through each catheter without difficulty.None of the stiffeners were broken or became broken during insertion or removal.The two components were able to be tightly locked together and remain locked.This process was repeated for the blue flexible stiffeners with the same results.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that appropriate controls are in place to address the reported failure mode.A review of the device history record (dhr) for lot 9992705 and the relevant catheter and stiffener subassembly lots showed related nonconformances for catheter occlusion and the shaft being difficult to wire.Catheters are 100% inspected for this failure during manufacturing and quality control.All nonconforming catheters were scrapped.It should be noted that there were two other complaints regarding difficult stiffener insertion into the catheter reported for this lot number.Based on the device history record and device failure analysis, there is no indication the complaint devices were manufactured out of specification.There is no evidence of nonconforming material in house or in the field.The instructions for use (ifu), provides the following information related to the reported failure mode: "precautions: when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture".Based on the information provided, examination of returned product and the results of our investigation, a definitive cause for the failure was a manufacturing deficiency.A capa was previously opened to investigate this failure and identified root causes related to supplier manufacturing of the catheter tubing.The complaint lot 9992705 was manufactured prior to corrective action implementation at the supplier.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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