Catalog Number 383033 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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Event Description
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It was reported that bd intima-ii y 24gax0.75in prn/ec slm had foreign matter.The following information was provided by the initial reporter, translated from chinese to english: "on (b)(6) 2023, when preparing to infuse the patient, after opening it and preparing for puncture, it was found that a foreign object was suspected to be attached to the needle site.The outer packaging was not damaged before use.If used carelessly, it may enter the patient's body and cause the risk of infection.Deprecated.".
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Event Description
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No additional information provided.
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Manufacturer Narrative
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1.Dhr/bhr review(lot#2076449): 1)this batch of products were assembled at intima ii auto line 2 in april 2022, and packaged at r240 package line in april 2022.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 defective samples and photos have been received for the complaint.3.Check the needle site of the retained samples of this batch, no foreign matter is found.Please see attachment for the photo.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 about this batch of products.Since the status and composition of the suspected foreign matter attached to the needle site cannot be confirmed, the root cause of this defect cannot be determined, and the plant will continue to track and trend for this issue.H3 other text : see narrative.
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Search Alerts/Recalls
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