The device, intended for use in treatment ,was returned for evaluation.A visual inspection reported no issues.The functional evaluation revealed the device had difficulty turning pump cartridge in u.I.Assembly was confirmed.Test pump cartridge could not be turned to the locked position due to corrosion inside u.I.Assembly, establishing a relationship between the device and the reported event.The root cause was identified as corrosion on the interlock.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.A complaint history review found further instances of the reported events this investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.
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