Catalog Number CU-25122-F |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/21/2019 |
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 in emergency icu of (b)(6), there was thrombus and floccule produced in the catheter during hemodialysis on the patient.Then they were removed by the doctor from the catheter by surgical techniques.
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Manufacturer Narrative
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Qn# (b)(4).The customer did not return a complaint sample; however, they supplied a photo of a representative sample.The image indicates the location on the catheter where the catheter was defective, but it cannot be determined without the actual sample to evaluate.A probable cause of the catheter becoming blocked cannot be determined from the photo and without the sample to evaluate.The report of a blocked catheter could not be confirmed from the customer supplied photo.The customer indicated that the sample in the image is a representative sample and is meant to show where the blockage was observed.The device history records were reviewed with no relevant findings to suggest a manufacturing related cause.The probable cause of the defective catheter could not be determined based upon the information provided and without the actual sample returned for evaluation.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 in emergency icu of (b)(6) hospital, there was thrombus and floccule produced in the catheter during hemodialysis on the patient.Then they were removed by the doctor from the catheter by surgical techniques.
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Search Alerts/Recalls
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