Catalog Number CV-17702-E |
Device Problem
Material Twisted/Bent (2981)
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Patient Problems
Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2024 |
Event Type
malfunction
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Event Description
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It was reported "complained of a slight pain, pulled out the swg, the swg was found kinked, the patient puncture site bleeding, pressure hemostasis, replacement of the swg." additional information reports, a new swg was used to succesfully complete the case.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
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Manufacturer Narrative
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(b)(4).
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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 "complained of a slight pain, pulled out the swg, the swg was found kinked, the patient puncture site bleeding, pressure hemostasis, replacement of the swg." additional information reports, a new swg was used to succesfully complete the case.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
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Search Alerts/Recalls
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