The 3-spike disposable set involved in the incident was not available for investigation, nor was the lot number available, therefore, review of a specific library/retain sample and batch record information is not possible at this time.Without the sample, or a lot number to evaluate, a root cause cannot be determined.No patient injury was reported.All 3-spike disposable sets are 100% leak tested and 100% visually inspected prior to release from belmont medical technologies.Following receipt of the complaint, belmont contacted the distributor to obtain further information about the case, and to discuss proper spiking techniques.Additional testing has been performed to ensure that the leak test challenges the bond of the tubing to the spike.Belmont will continue to monitor and trend similar reports of this nature and take further action if required.Should additional information become available, a supplemental report will be provided.
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