H4: the device was manufactured between march 23, 2023 ¿ march 27, 2023.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the provided photographic samples revealed a non-baxter broken syringe tip stuck inside the infusor¿s fill port.The reported condition was verified.However, due to the nature of the provided sample, no further testing could be performed.Therefore, the cause of the condition could not be determined; however, based on historical data of similar reported complaint from returned samples, the probable cause may be related to either a defective syringe or excess force applied onto the syringe tip by the handler during fill.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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