[3450934]
On (b)(6) 2013, we were scheduled to undergo a frozen embryo transfer at (b)(6). Right before the transfer, we were advised that the straw containing our embryos "shattered" when it was removed from the liquid nitrogen, and both embryos contained in the straw were destroyed. We were advised that irvine scientific (is) would "fly out" a representative immediately to investigate what happened. After repeated requests for information, we were advised on (b)(6) 2013 by our doctor that "[they] do not know exactly what caused the break. A representative from the company that makes the straws is supposed to come by our lab the next time he is in the area, which should be soon. " we met with the lab manager and doctors on (b)(6) 2013 and were advised that "is" had still not come to investigate the cause our straw breakage/embryo destruction. We were shown photos of the pieces of the straw that were recovered, and told that the "seal was intact" so that the break was apparently due to a defect in the straw. The lab manager confirmed that the straw was a cryotip vitrification straw (closed system). Information on the internet shows that those straws are touted as being shatterproof, so we could not understand why the manufacturer was failing to look into the issue with our straw. The lab manager said that he would try again to get "is" to engage on the issue. We then contacted "is" personally on multiple occasions to request information and spoke once with a district sales rep, who said someone from corporate was planning to contact us. We left additional messages, but have received no communication from "is. " a representative from our doctor's office has since advised us that it was her understanding that it is "is's" "policy not to speak with patients. " we were advised on (b)(6) 2013 by the hospital quality management representative that two people from "is" visited the lab the previous week, and that "we will probably never know what happened. " we have been unable to obtain any additional information, or get "is" to contact us to discuss the issue. I spoke with a rep from the fda on (b)(6) 2013 to inquire if any information had been submitted about the event to the fda, and the fda representative said that no report had posted yet and requested that i file this report.
Patient Sequence No: 1, Text Type: D, B5