Model Number IPN031223 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/06/2021 |
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 "the puncture needle is leaking - aspiration is not possible, when the needle is flushed it comes out from the sides." no patient harm reported.
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Event Description
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It was reported that "the puncture needle is leaking - aspiration is not possible, when the needle is flushed it comes out from the sides." no patient harm reported.
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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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Search Alerts/Recalls
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