Returned for evaluation was one soft-vu catheter.A visual review of the catheter noted that the tip was fractured,.3cm from the weld joint.The customer's reported complaint description of soft-vu tip fracture is confirmed.The defect was discovered prior to making patient contact.Although the complaint description is confirmed, a root cause for the defect cannot be determined.A review of the lot 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.The instructions for use, which is supplied to the end user with this catalog number, contains a statement; "reshaping of catheter tip is not recommended.Physical damage to the catheter material can result when exposed to heat".Capa (b)(4) was initiated to determine the root cause and implement a corrective / preventative action for this type failure.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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