According to the facility on (b)(6) 2023 "foley catheter was leaking and the catheter was removed and a new one was placed".Per the facility the balloon was tested prior to insertion and 10cc's were used to inflate the balloon.The catheter was used in an acute care setting and there were no issues identified at the time.No additional information is available at this time.The sample is not available to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
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