It was reported that the temperature sensing foley catheter that was filled with 10cc of sterile water prior to use, was deflated intraoperatively.Upon checking the balloon, there was a small hole in the catheter.The patient experienced inconvenience.No medical intervention was reported.
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The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Root cause could not be identified.Although a root cause could not be definitively identified, a potential root cause for this type of failure could be "imperfection in balloon due to process".However, this potential root cause could not be confirmed.Product labeling was reviewed for this investigation.The labeling is found to be adequate as the instructions for use stated that "sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use".Based on the results of the investigation, no additional actions are needed.A dhr review is not required as the lot number is unknown.H11: section a: through f: the information provided by bd represents all 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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