TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL; CATHETER, RETENTION TYPE, BALLOON
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Catalog Number 170605-000140 |
Device Problem
Unintended Deflation (4061)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#(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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Reported issue: twice we faced malfunction of these devices.The catheters got pierced and became porous.The 2 catheters were found in the patient's bed, balloon deflated, despite the use of different sizes ch14 and ch16.
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Event Description
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Reported issue: twice we faced malfunction of these devices.The catheters got pierced and became porous.The 2 catheters were found in the patient's bed, balloon deflated, despite the use of different sizes ch14 and ch16.
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Manufacturer Narrative
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(b)(4).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.Catheter with defective balloon will be culled out during this process.In conclusion, since no actual sample returned for this complaint, any further investigation was not possible.Therefore, this complaint could not be confirmed.
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