The reported event was confirmed as manufacturing related.The evaluation found a pinhole at the rubberized layer that had caused water to leak out.The origin of the pinhole could not be determined.The event described could be confirmed as a manufacturing related issue.The device history record was reviewed and found a possible manufacturing issue(s) that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "[contraindications] 1.Method for use: (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)do not use in patients who are or have been allergic to natural rubber latex".
|