Model Number IPN923531 |
Device Problem
Inflation Problem (1310)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
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Event Description
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The report states that "it was reported that the balloon did not inflate from the first inflation during use.Therefore, the catheter was removed and replaced with another catheter from a new kit, which was inserted at the same insertion site.There was no problem during the inflation test and when inserting the catheter." no report of patient harm or injury.Patient status reported as "fine".
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Event Description
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The report states that "it was reported that the balloon did not inflate from the first inflation during use.Therefore, the catheter was removed and replaced with another catheter from a new kit, which was inserted at the same insertion site.There was no problem during the inflation test and when inserting the catheter." no report of patient harm or injury.Patient status 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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