The reported event was confirmed however the cause was unknown.Evaluation found that the valve and cap were disconnected from the inflation funnel of the catheter.There are dents observed on the inflation funnel which indicates that the valve and cap were placed prior to the detachment.The exact cause of how and when the problem occurred could not be determined.However, the potential root cause for this failure mode could be due to improper placement of valve and cap, rough handling by user.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: (1) do not inflate the balloon in the urethra.(the urethra may be injured) (2) 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 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) 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.] (4) 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 on patients who are or have been allergic to natural rubber latex." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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