As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of tunneler/sleeve/catheter connection issue (loose/detached) cannot be confirmed, no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.The tunneler sleeve accessory is supplied to angiodynamics by the supplier (b)(4).Scar004238 was sent to (b)(4) for dhr review of affected supplier lot.As per scar004238 results from (b)(4), the dhr review showed no issues with the production paperwork.The tri-ball tunneler accessory is supplied to angiodynamics by the supplier (b)(4).Scar004227 sent to the supplier, (b)(4) for dhr review of supplier lot.As per scar004227 results from (b)(4).The dhr review showed no issues with the production paperwork.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: the following is provided as a reference from dfu: warning: do not over-expand subcutaneous tissue during tunneling.Over-expansion may delay/prevent cuff in-growth.6.Lead catheter into the tunnel gently.Do not pull or tug the catheter tubing.If resistance is encountered, further blunt dissection may facilitate insertion.Remove the catheter from the trocar with a slight twisting motion to avoid damage to the catheter.Precaution: do not pull tunneler out at an angle.Keep tunneler straight to prevent damage to catheter tip.Note: a tunnel with a wide gentle arc lessens the risk of kinking.The tunnel should be short enough to keep the y-hub of the catheter from entering the exit site, yet long enough to keep the cuff 2 cm (minimum) from the skin opening.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).
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