The reported event was unconfirmed since the problem could not be reproduced.The evaluation observed that the surface of the catheter had a change in color that appeared to have been in use for a long period.The catheter was able to inflate and deflate without any difficulty.However, the defect was unable to determine for returned sample due to the water that retrieve from catheter was not show any color changes.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿general used if there is no specific defect (1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients (1) patients who are or have been allergic to natural rubber latex (2) patients with known allergy to silver coated catheter".
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