Model Number IPN037640 |
Device Problem
Obstruction of Flow (2423)
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Patient Problems
Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/03/2021 |
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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Customer complaint reports "the catheter gets blocked quickly, within 48 hours.So we can't performed blood sample then.And we have to replace the catheter quicker than previously." patient had a right radial catheter that was "dysfunctional" 1 day after insertion.Clinician performed seal test, flushing, rinsing the device with a syringe and checking the back pressure on the line.Device ultimately replaced with new catheter inserted in left radial site.It was reported this new catheter was described as "dysfunctional" requiring replacement again (captured in 3006425876-2021-00663).Customer reports concern for risk of vascular injury with frequent catheter change.No patient injury was reported.
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Manufacturer Narrative
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Qn# (b)(4).Additional information received from customer indicates the patient had a bilateral radial artery thrombosis following catheter insertion.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.Corrected data: section f.10.-health effect clinical code corrected to 4440.Section h.6.-health effect clinical code corrected to 4440.
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Event Description
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Customer complaint reports "the catheter gets blocked quickly, within 48 hours.So we can't performed blood sample then.And we have to replace the catheter quicker than previously.".Patient had a right radial catheter that was "dysfunctional" 1 day after insertion.Clinician performed seal test, flushing, rinsing the device with a syringe and checking the back pressure on the line.Device ultimately replaced with new catheter inserted in left radial site.It was reported this new catheter was descrbed as "dysfunctional" requiring replacement again (captured in 3006425876-2021-00663).Customer reports concern for risk of vascular injury with frequent catheter change.No patient injury was reported.
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Search Alerts/Recalls
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