TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL; CATHETER, RETENTION TYPE, BALLOON
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Catalog Number 170605-000180 |
Device Problem
Unintended Movement (3026)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/20/2022 |
Event Type
malfunction
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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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Event Description
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It was reported that: incidents occurred in an elderly house.On several occasions, we found residents without their catheters but with the balloon being inflated or deflated.That happened before the date of scheduled catheter change; 6-week period between two catheter changes.We also faced catheter blockages.We must perform numerous washes and therefore disconnect the closed system because the deposits obstruct the catheters.The patients are re-catheterized.Additional information: for one patient, two catheters self-expelled whereas the balloon was still inflated but there was no trauma, no bleeding for the female patient.It happened two days in a row.Balloon inflated with 10 ml of sterile water.
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Manufacturer Narrative
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Qn#(b)(4).No alleged sample was returned for investigation.Hence, investigation shall be conducted based on document review.The catheter self-expelled may be due to several potential factors such as leakage, asymmetrical balloon or balloon not sufficiently inflated.Since no actual or representative sample was returned, the asymmetry ratio could not be measured.In 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.Catheter with defective balloon will be culled out.There are several potential root causes that may cause the catheter to self-expelled with balloon in inflated condition.However, without the presence of the physical sample, the root cause could not be identified.Therefore, this complaint could not be confirmed.
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Event Description
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It was reported that: incidents occurred in an elderly house.On several occasions, we found residents without their catheters but with the balloon being inflated or deflated.That happened before the date of scheduled catheter change; 6-week period between two catheter changes.We also faced catheter blockages.We must perform numerous washes and therefore disconnect the closed system because the deposits obstruct the catheters.The patients are re-catheterized.Additional information: for one patient, two catheters self-expelled whereas the balloon was still inflated but there was no trauma, no bleeding for the female patient.It happened two days in a row.Balloon inflated with 10 ml of sterile water.
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Search Alerts/Recalls
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