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 02/21/2023 |
Event Type
malfunction
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Event Description
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"it was reported that the catheter got torn near the hub during use, in spite that the maximum injection pressure was kept less than 520psi.Therefore, the catheter from a new kit was inserted at the same insertion site to complete the procedure.No harm to the patient was reported." the patient condition is reported as "fine".
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Manufacturer Narrative
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Qn# (b)(4).
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Event Description
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"it was reported that the catheter got torn near the hub during use, in spite that the maximum injection pressure was kept less than 520psi.Therefore, the catheter from a new kit was inserted at the same insertion site to complete the procedure.No harm to the patient was reported." the patient condition is reported as "fine".
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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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Search Alerts/Recalls
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