Additional information: d4, d9, h3, h4, h6, h10.H4: the lot was manufactured between may 3, 2023 - may 5, 2023.H10: the actual device was received for evaluation.Visual inspection was performed which identified a black colored particle embedded in the material of the tubing line.The particle was not in the fluid path because it was molded in the material of the tubing line.The particle was identified to be polyvinyl chloride (pvc) material via fourier transform infrared spectroscopy (ftir) test; pvc is the material of the tubing line.The reported condition was verified.The cause of the condition was determined to be related to manufacturing.However, the embedded particle is unlikely to cause harm and does not impact the sterile pathway.Particulate outside of the fluid path does not impact the product delivered to the patient.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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