Reportedly, the tubing on one cryocyte freezing container broke from the bushing during transport from storage tank to transport tank. Cells were discarded at the time of the event. Sufficient back up cells were on hand for transplantation. No adverse pt event reported in association with the breakage. The containers are fragile when frozen and great care must be taken not to mechanically damage the containers when transporting from one area to another. Any contact may have caused the tubing to break while frozen. Containers were disposed of at time of event.

Baxter healthcare ("baxter") submits the following report, together with any telephone or written reports on the same incident, to the fda pursuant to the provisions of 21 cfr part 803. These reports are based on info received by baxter which baxter may not have had any opportunity to investigate or verify prior to the required reporting date. These reports shall not be construed as an admission by baxter that the product(s) , described herein, are products of its manufacture and are or were defective or dangerous products in any respect, or that any casual relationship exists between these products and any actual or potential injury. In addition, the submission of a report by baxter shall not be construed as an admission that a reportable event has in fact occurred.