According to the facility on (b)(6) 2014 "the foley catheter balloon ruptured and fell out of the patient".Per the facility the ballon was not tested prior to insertion and 10cc's of fluid were used to inflate the balloon.Per the facility the catheter was replaced when this occurred, and the patient experienced "irritation and pain".No additional information is available at this time.The sample was requested for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
|