The reported event is confirmed cause unknown.Visual evaluation noted received a 2-way catheter.Visual inspection noted that the catheter was broken into 2 separate pieces originating at the bifurcation.Although an exact root cause could not be determined potential root causes include: over exposure to ozone resulting in product degradation.Exposure to petrolatum based products.High modulus silicone.Inadequate material selection.The product was used for patient diagnostic or treatment.The product was influenced by the reported event.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 luer slip tip 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." 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.
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