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Model Number IPN917235 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2023 |
Event Type
malfunction
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Event Description
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"it was reported that when the contrast medium was being injected at 450psi after insertion of the catheter, leak from the catheter occurred.The user replaced the catheter with a new one, inserted at the same insertion site, but the same issue occurred.Therefore, he/she stopped using berman catheter and injected the contrast medium via another route from the sheath that had already been placed, by which could complete the procedure." the patient condition is reported as "fine".See associated mdr 3010532612-2023-00126.
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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 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.Other remarks: n/a.Corrected data: n/a.
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Event Description
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"it was reported that when the contrast medium was being injected at 450psi after insertion of the catheter, leak from the catheter occurred.The user replaced the catheter with a new one, inserted at the same insertion site, but the same issue occurred.Therefore, he/she stopped using berman catheter and injected the contrast medium via another route from the sheath that had already been placed, by which could complete the procedure." the patient condition is reported as "fine".See associated mdr 3010532612-2023-00126.
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Search Alerts/Recalls
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