The 3-spike disposable set was discarded at the hospital, and was not available for investigation.Upon reviewing photographs provided by the distributor, we were able to confirm that there was a leak at the lower reservoir connection as reported, however, it is difficult to determine the root cause of the leak without investigating the set.A visual inspection of the library/retain sample for this lot number was performed, and no evidence of any defects was observed.The manufacturing batch records for this lot were also reviewed and no anomalies were identified.All 3-spike disposable sets are 100% leak tested prior to release from belmont medical technologies.A review of past complaints indicates that there have been no additional leaks reported with this lot number.It was reported that the user was able to continue the procedure, and there was no injury to the patient.Should additional information become available, a supplemental report will be submitted.
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