It was reported that the catheter was "decomposing" while in use with the patient.The balloon and the hole behind the balloon that is inside the body was "discolored and deformed".It was reported that due to this, the catheter was replaced two weeks early due to leaking.A sample was requested to be returned 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.
|