ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR; CATHETER, HEMODIALYSIS, IMPLA
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Catalog Number CS-15232-VFE |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/31/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that, when the user checked the catheter with x-ray after placement, it was found kinked.According to the user, there seemed to be no problem with blood flow in the catheter, so he/she continued to use it as it was.It occurred to two catheters.Associated to 9680794-2023-00699.Additional information: the patient had hemodialysis performed, the kink in the catheter did not affect the treatment.It was kinked 23cm from the tip.The catheter was placed in the right jugular vein.It was possible to flush the catheter without issue.The patient was reported as fine.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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It was reported that, when the user checked the catheter with x-ray after placement, it was found kinked.According to the user, there seemed to be no problem with blood flow in the catheter, so he/she continued to use it as it was.It occurred to two catheters.Associated to 9680794-2023-00699.Additional information: the patient had hemodialysis performed, the kink in the catheter did not affect the treatment.It was kinked 23cm from the tip.The catheter was placed in the right jugular vein.It was possible to flush the catheter without issue.The patient was reported as fine.
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