It was reported that the balloon was stuck in the prostate gland and with damage to the urethra.Reportedly, no urine flowed and the balloon was difficult to deflate.A needle was eventually used to burst the balloon under the scrotum and the catheter was removed.Per additional information received via email on 08jul2020 from ibc representative, no urine flowed when the catheter was inserted into the patient which resulted in removal of catheter.
|
The reported event was inconclusive due to poor sample condition.Potential root cause for this failure mode could be user related (example: salt accumulation)/block drainage lumen/no drainage eye).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: "[warnings] 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 may be 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) patients who are or have been allergic to natural rubber latex (2) patients with known allergy to silver coated catheter." 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.
|
It was reported that the balloon was stuck in the prostate gland and with damage to the urethra.Reportedly, no urine flowed and the balloon was difficult to deflate.A needle was eventually used to burst the balloon under the scrotum and the catheter was removed.Per additional information received via email on (b)(4) 2020 from ibc representative, no urine flowed when the catheter was inserted into the patient which resulted in removal of catheter.
|