The reported issue was unconfirmed.The device was returned and visually inspected.Evaluation found that the catheter could be inflated and deflated without difficulty.No blockage was observed during inflation and deflation process.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: ¿[directions for use] 1.Method of use the device is intended for single use only and is not reusable.(6) insert catheter into the urethral meatus, and advance it until the balloon enters the bladder and urine flows out through the catheter.Using a syringe packaged in the tray, infuse the specified volume of sterile water into the inflation lumen to inflate the balloon." 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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