(b)(6).The device was received for evaluation.During visual investigation, it was noted that the returned product showed signs of use (dried blood) which is consistent with the reporter¿s statement that the alleged event occurred during use.The reported condition was verified.However, the cause of the condition could not be determined because the returned coupler rings had been successfully approximated (brought together aligned and tightly closed) and were no longer attached in the ¿u port) of the coupler jaw assembly.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.
|