It was reported that bd intima-ii y 24gax0.75in prn/ec slm catheter broke.The following information was provided by the initial reporter, translated from chinese to english: the indwelling needle catheter broke, cannot be used normally, replaced the new indwelling needle, puncture again.
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1.Dhr/bhr review (lot#: 0019806).1) this batch of products were assembled at intima ii auto line 4 in march 2020, and packaged at cfs package line in march 2020.Work order quantity was (b)(4) ea.2) review the in-process test reports and outgoing test reports, and all test results meet the product specifications.3) review the production records with no nonconformance, deviation or rework activities.4) review incoming inspection records of catheter, no abnormalities.(material number: b5171aaal, batch number: 9248035).2.No defective samples and photos have been received for the complaint.3.The retained sample of this batch is taken, and the catheter head and surface are examined under the microscope.No abnormality is found.4.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s).No abnormality is found on process and retained sample, and no similar complaints have been received from other hospitals regarding this batch of products.As the specific site and state of the breakage of the catheter cannot be confirmed, the root cause of this defect cannot be confirmed.
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