TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL; CATHETER, RETENTION TYPE, BALLOON
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Catalog Number 170605-000180 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/18/2023 |
Event Type
malfunction
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Event Description
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Reported event: at the end of a robotic prostatectomy, when re-positioning the patient on the operating table, a nurse noticed a lea k of liquid at the level of the catheter, near the junction of the tubing and the funnel of the catheter.To avoid any surgical risk, it was decided to occlude the hole with a strip + opsite.
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Manufacturer Narrative
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(b)(4).According to the complaint description, the device was having leakage.There was no complaint sample returned for investigation.Therefore, no physical assessment could be conducted, and investigation will be based on documentation review.Leakage of the catheter may happen due to several reasons such as being in contact with sharp object during use i.E.Contact with clamper, kidney dish/tray.In our current standard operating procedure, the products are subjected to 100% visual inspection and any defective raw balloon will be culled out before sent to the next process.Upon completion of assembly process, the finished catheter will be again subjected to 100% balloon inspection and 20 minutes leak test.Catheters with defective balloons will be culled out during this process.In conclusion, due to no actual sample returned for this complaint, any further investigation was not possible.Therefore, this complaint could not be confirmed.
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Event Description
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Reported event: at the end of a robotic prostatectomy, when re-positioning the patient on the operating table, a nurse noticed a lea k of liquid at the level of the catheter, near the junction of the tubing and the funnel of the catheter.To avoid any surgical risk, it was decided to occlude the hole with a strip + opsite.
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Search Alerts/Recalls
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