Pro codes: fqh (lavage, jet) and fro (dressing, wound, drug).No photos or physical samples were received for evaluation; therefore, the incident could not be verified.The reported lot's (1854588) device history records were reviewed.All process and final inspections meet specifications.An in-depth investigation as part of that capa has been performed to identify the cause of the surgiphor bottle cracking during use.At this time this investigation discovered that the combination of the following variables are probable causes that contribute to the failure mode of surgiphor containers cracking during use: aging, bottle wall thickness/bottle weight, inspected product returned into the manufacturing lot, and upper end of the gamma sterilization dosages of the product.A follow-up will be sent if additional information is received.
|