Investigation ¿ evaluation: the investigation included a review of complaint history, the device history record, drawings, manufacturing instructions, and specifications.The actual needles used in this complaint were not returned.A visual inspection and functional testing of returned unused product was conducted.Three unopened packages containing a j-dan-201501 were returned for investigation.With the assistance of the senior engineer, research, the devices were checked with the sonosite l38/10-5 ultrasound probe/¿l38/10-5 mhz 38mm linear array transducer.All three needles visibility was clear and bright in the ultrasound.The device history record review found there are no non-conformances associated with the complaint device lot number 7872604.A review of complaint history shows this to be the only complaint received associated with complaint lot number 7872604.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.Based on the provided information a definitive root cause cannot be established for the report of ¿the needle could not be seen during the amniocentesis procedure¿.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
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