Investigation summary: received a 20ga nexiva catheter-adapter extension set dual port unit wrapped on surgical tape along with a piece of top web (packaging) from lot number 7349564.The needle-tip shield assembly and needle cover were not received for evaluation.The unit revealed traces of blood and the pinch clamp was fully engaged.Dhr review: the lot was manufactured on nfa line 1 from 20dec17 through 2jan18.A non-related qn (200725749) for incomplete seal was initiated-quality plan was followed.All other challenge, set-up and in process samples were performed per quality plan and all passed per specifications.Visual/microscopic examination: no physical-mechanical damage was observed on any of the components of the unit received.No holes, bends, splints, kinks or wrinkles were observed on catheter tubing the extension tubing was not cut or damaged water-leak test: no leakage was observed on any of the areas of the unit received.Fluid-flush test: using a lab provided syringe filled with water-food coloring solution flushed the liquid through the unit (pinch clamp not engaged).Flush was successful, no obstruction was observed.Then, engaged the pinch clamp and attempted to push the liquid through, the liquid did not flow, the pinch clamp performed as intended.Conclusion(s):flashback test was successful, the cannula revealed damage on its tip (blunt) eura (end user risk analysis) findings: the failure mode and cause of failure could not be determined as the returned unit did not display any adverse characteristics that would contribute to the defect as described by the customer.Rm5769 rev 14(m) nexiva a-eura has identified inadequate flush of the device as a failure mode and assessed the current risk to the end user as acceptable.Rm5619 rev 17(o) nexiva d-eura has identified blood reflux back into the device due to inadequate engagement of the pinch clamp as a failure mode and assessed the current risk to the end user as acceptable.Root cause for this incident is indeterminate.The returned unit did not display any adverse characteristics that would contribute to the defect the customer experienced.The defect described in the incident report could not be confirmed or replicated.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a quarterly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
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