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Model Number IPN050265 |
Device Problem
Sharp Edges (4013)
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Patient Problems
Pain (1994); Discomfort (2330); Genital Bleeding (4507)
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Event Date 07/31/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: n/a.Corrected data: n/a.
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Event Description
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It was reported that "when the catheter was removed, this led to very heavy bleeding with a clot in the patient's urethra, which necessitated the use of bladder washes." as a result, a new catheter was inserted.There was "no visible bleeding at the level of the bladder, user thinks there might be a problem of friction between the catheter and the urethra." the patient status is reported as "fine.".
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Manufacturer Narrative
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(b)(4), there was no sample returned for investigation.However, in review of a previous complaint retained sample product catalogue 171305-000180 and lot number kme21j0029 no sharp edges, kink, flashing or any damage was observed.In review of the ifu for the product there are contraindications and potential complications during usage of this catheter included.Verification of the reported defect cannot be conducted without the returned product.Device history record (dhr) review was conducted for the lot number kme23c1254 with no relevant findings.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 that "when the catheter was removed, this led to very heavy bleeding with a clot in the patient's urethra, which necessitated the use of bladder washes".As a result, a new catheter was inserted.There was "no visible bleeding at the level of the bladder, user thinks there might be a problem of friction between the catheter and the urethra".The patient status is reported as "fine".
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Search Alerts/Recalls
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