Evaluation is in progress, but not yet concluded.(b)(4).A sample was received and decontaminated.Both visual and photographic review indicated that there was crazing on the female large bore luer, and a crack parallel to the parting line.The sample was also tested for leaks and was found to leak at a pressure of 20 mmhg.A representative sample was used to test the impact of solvent exposure to the connector, the test showed that no cracking on crazing occurred when exposed to solvent for 20+ hours.Another representative sample was used to test the impact of over tightening the luer when mated with the male counterpart.No cracking or crazing occurred as a result of this test.The sample will be sent to supplier for further evaluation.The device history record (dhr) was reviewed and there were no issues noted.The incoming raw material documentation, including the certificate of conformance and inspection results, were reviewed and there were no issues noted.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.(b)(4).
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The customer reported that during cardiopulmonary bypass (cpb) procedure, the large luer on end of line (17b, l2) was a cracked and leaking.It resulted in approximately 5 cc blood loss.The device was changed out.The surgical procedure was completed successfully but there was a 5 minutes delay occurred.
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