The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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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Received 1 used catheter with drainage bag.The reported event was confirmed as use related.The exterior of the sample was inspected and encrustation was found in the drainage eye and on the balloon.Per functional testing, the balloon was inflated with 10cc of water and no water flowed through the drain lumen.This was repeated with the balloon deflated and no water flowed through the drain lumen.The testing did not meet minimum flow rate requirements of 150cc/min.The catheter was dissected and encrusted matter was packed on the inside of the drain lumen and obstructed the flow of water.This is a patient related condition with use that is dependent on many variables, such as diet and medication.However, this is not a manufacturing related condition.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "periodic observations of this system should be made to ensure that urine is flowing freely.If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed." (b)(4).
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