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(b)(6).Occupation: unknown.Pma/510(k) #: preamendment.Investigation - evaluation: (b)(6) hospital north (united states) reported that on (b)(6) 2019, 2 needles in c-pms-250 (single lumen pressure monitoring set) sets from lot 9826829 seemed to be "blocked" during an arterial line placement.The physician had difficulty inserting a wire through the needle.They opened another device to complete the procedure without adverse effects to the patient.A review of documentation including the complaint history, device history record (dhr), instructions for use (ifu) and quality control of the device, as well as a functional test and visual inspection of unused returned product was conducted during the investigation.One unopened c-pms-250 tray from the same lot as the two that failed was returned to cook for evaluation.The tray was opened and a.015" wire guide was inserted into the needle without difficulty.Nothing exited the cannula.The two used devices were not returned to cook.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that there is an inspection protocol in place to address this failure mode before distribution.A review of the design history file found that this device is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (9826829) and the related needle sub-assembly lots was also completed.Needles included in these devices are supplied by cook polymer technology (cpt).While no non-conformances were recorded in these dhrs, there is evidence of nonconforming material from the same supplier lots in other complaint investigations.It should be noted that three additional complaints were reported for these lots.Consequently, cook initiated a supplier corrective action request as well as a containment to prevent the distribution of nonconforming product in house.Cook also reviewed product labeling.The instructions for use that are supplied with the device state "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, inspection of the returned product, and the results of the investigation, a definitive root cause was traced to deficiencies in manufacturing/quality control.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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It was reported that the wire guides would not pass through the needles included in two single lumen pressure monitoring sets from the same lot during an arterial line placement, citing that the wire is catching.The first device was being implanted in the pediatric cardiac intensive care unit (pcicu) but did not make patient contact as it was tested prior to the procedure.Another device was then obtained, but the same issue was experienced.A third device was used to complete the procedure.The user facility has stated that no further information is available.
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