The reported event was confirmed manufacturing related.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment.The product had caused the reported failure.A potential root cause for this failure could be inserts with edges (operator hits the tube against the bottom insert when removing the piece from the mold).The device history record was reviewed and found a possible manufacturing issue(s) 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." h11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was evaluated.
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