Correction: h6- device code: complete blockage (1094) is the only device code for this event.Investigation - evaluation: a customer at kalispell regional hospital (united states) reported that the needle in a c-pmsy-250 (single lumen polyethylene central venous catheter tray) from lot 9001278 was occluded during an arterial line placement on (b)(6) 2019.The physician attempted to cannulate the patient's right radial artery with the needle, but did not get blood return.They completed the procedure with a new needle.The patient did not experience adverse effects.A review of the complaint history, device history record (dhr), quality control and trends, as well as a visual inspection and functional test of the returned device, was conducted during the investigation.One used 22g needle was returned to cook for evaluation.Upon visual inspection, a buildup of coating native to the device was noted to be on the outside of the needle cannula.No visible damage or biomatter was noted.A functional test of the device showed that a wire guide was not able to be inserted through the needle.Additionally, a document-based investigation evaluation was performed.The device master record (dmr) found that proper procedures and inspections are in place to prevent the distribution of non-conforming product.A review of the device's design history files found that the product is both safe and effective for its intended use.A review of the dhrs for the reported complaint device lot (9001278) and the related needle component sub-assembly lots revealed no non-conformances.However, based on the dhr review, there is evidence of potential nonconforming material in house and in field.As the needle is supplied by cook polymer technology (cpt), cook initiated a supplier corrective action request in response to this issue.As there is evidence of potentially nonconforming material from the same supplier lots in other events, cook initiated product containment for affected in house product and to prevent redistribution of product in the field.No other additional events were found to be associated with any of the final lots.Cook also reviewed product labeling.The instructions for use state "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, examination of the returned product, and the results of our investigation, a definitive root cause was established as a deficiency in supplier 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.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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