It was reported that bd intima-ii y 24gax0.75in prn/ec slm package was damaged the following information was provided by the initial reporter: on (b)(6) 2023, at approximately 9:00 a.M., a routine pre-use check of an indwelling needle prior to infusion for a patient revealed a leak in the outer packaging, which was replaced with a new indwelling needle; this incident did not result in any adverse effects to the patient.
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1.Dhr/bhr review(lot#1320170): 1)this batch of products were assembled at intima ii auto line 2 in (b)(6)2021, and packaged at cfs package line in (b)(6) 2021.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.2.No actual samples and photos have been received for the complaint.3.Check the unit packages of the retained samples of this batch, and no poor seal, broken top web or broken bottom film is found.Please see attachment for the check report.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 samples, and no similar complaints have been received from other hospitals regarding this batch of products.As the specific site and state of the leakage of the package cannot be confirmed, the root cause of this defect cannot be determined.H3 other text : see narrative.
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