The reported issue was confirmed.The device was returned for evaluation.Visual inspection of the returned sample noted one opened (without original packaging) silicone foley with a balloon cuff.The catheter balloon was inflated with 10ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and balloon concentricity was observed to be 60:40.The balloon rested for 30 minutes without leaks and passively deflated without issue, returning 10ml of solution.Active length of the catheter balloon was measured (0.7645") and was found to be within specification (0.6"-0.9").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: ¿to deflate catheter balloon: gently insert a syringe in the
catheter valve.Never use more force than is required to make
the syringe ¿stick¿ in the valve.If you notice slow or no deflation,
re-seat the syringe gently.Allow the balloon to deflate slowly on
its own.Do not aspirate or manually accelerate the deflation of
the balloon.If permitted by hospital protocol, the valve arm may
be severed.If this fails, contact adequately trained professional
for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure
that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface
deterioration prior to use.".
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