The reported event was confirmed as manufacturing related.The sample was evaluated and a tear was observed on the rubberize layer that caused the interlumen leak.Per the zoomed photo, it is possible this was created when the operator removed the catheter from the wire/former during the stripping process.The device history record was reviewed and found a possible issue(s) that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿(1)do not inflate the balloon in the urethra.[the urethra may be injured.].(2)do not pull the catheter hard.[the bladder/urethra may be injured.].2.Applicable patients: patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [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)patients who are or have been allergic to natural rubber latex.(2)patients with known allergy to silver coated catheter".
|