The reported event was confirmed.The exterior of the sample was inspected and found that the inflation valve was detached.The edges of the inflation funnel were smooth and regular.How and when the event occurred could not be determine.A potential root cause for this failure mode could funnel thickness incorrectly sized at build-up or finish dipping operations/ machine misalignment during valve/cap assembly/user related (rough handling or incorrect syringe used).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: "1.Method for use: do not inflate the balloon in the urethra.(the urethra may be injured).Do not pull the catheter hard.(the bladder/urethra maybe injured).2.Applicable patients (1) patients with delirium who might pull out catheter (when patient tugs at catheter unconsciously, the bladder and urethra may be damaged).Contraindications method for use: do not reuse.Do not resterilize.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].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].Applicable patients: do not use on patients who are or have been allergic to natural rubber latex.".
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