Catalog Number ASK-17702-KR |
Device Problems
Hole In Material (1293); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/26/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device is not intended for sale in the us.A similar device is sold in the us.
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Event Description
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The customer alleges that during removal of the catheter, the user found the 2nd hole (distal port) from the top of the catheter seemed bigger than normal one.The catheter was in place for 3 weeks.
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Manufacturer Narrative
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(b)(4).The customer returned a used 2-lumen 7fr x 20cm cvc kit catheter.The catheter appeared used; however, no defects or anomalies were observed.The proximal lumen skive hole measured 3.54 mm in length which is within specification.The distal lumen skive hole measured 1.29 mm in length which is also within specification.The catheter was leak tested by injecting water into each extension line using the lab leak tester.Each lumen was pressurized with water to 45psi for 30 seconds.The distal end of the catheter was capped off during testing to restrict flow.No leaks were observed in the distal lumen.The proximal lumen was unclogged using a laboratory inventory long pin gage.Once unclogged, the proximal lumen was leak tested and no leaks were observed.A device history record review was performed and no relevant findings were identified.The reported complaint of a catheter leak and an incorrectly sized catheter skive hole could not be confirmed based on the sample received.There were no anomalies found on the catheter during visual inspection , the catheter did not leak during functional testing, and the catheter met dimensional requirements.No problem was found with the returned catheter.
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Event Description
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The customer alleges that during removal of the catheter, the user found the 2nd hole (distal port) from the top of the catheter seemed bigger than normal one.The catheter was in place for 3 weeks.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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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The customer alleges that during removal of the catheter, the user found the 2nd hole (distal port) from the top of the catheter seemed bigger than normal one.The catheter was in place for 3 weeks.
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Search Alerts/Recalls
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