Received for evaluation was an unopened soft-vu catheter.A visual review of the catheter noted that the tip was fractured inside the pouch.The customer's reported complaint description of soft-vu tip fracture is confirmed.A root cause for this reported complaint description cannot be determined.A review of the lot history records was performed for the reported lot for any deviations.The review confirms that the lots met all material, assembly, and performance specifications.During the manufacturing process, the device goes through several aql inspections before packaging.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint #(b)(4).
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