(b)(4).The actual devices involved in the reported incident were not returned for evaluation.Incidents of cracked/leaking valves can be caused by many factors, including but not limited to an excess torque force in combination with over-tightening the connection; if the product is subjected to aggressive solvents, excessive mechanical stresses, or other various unforeseen circumstances during the clinical application.However without the actual sample, a thorough sample analysis could not be performed and no specific conclusions can be drawn.Review of the discrepancy management system database performed for the reported lot numbers did not reveal any abnormalities or nonconformances of this nature.If the physical sample is received or if additional pertinent information becomes available, a follow-up report will be filed.
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(b)(4).Twenty-five (25) used sets and fifty-three (53) unused sets were received for evaluation.All twenty-five (25) used sets were leakage tested per specification, and no nonconformances were noted.Ten (10) of the unused samples were leakage tested per specification, and no nonconformances were noted.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.The returned set met requirements according to specification, and the reported failure could not be reproduced.Although a definitive conclusion could not be made regarding the cause of the reported event, cracking of this nature can occur when the product is subjected to aggressive solvents/drugs, excessive mechanical stresses (over-tightening), or other various unforeseen circumstances during the clinical application.If additional pertinent information becomes available a follow-up report will be filed.
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