H10: manufacturing review: a lot history record could not be completed as the lot number was not provided.Investigation summary: one clearvue port was returned for evaluation.A visual, microscopic and functional evaluations were performed.The investigation is unconfirmed for the reported infection issue to the device, as the port body with attached catheter segment was patent to infusion and aspiration.Blood was noted exiting the catheter segment.Multiple punctures were observed on the port septum.Striations were noted on the edge of the break.Furthermore, the surface of the break appeared smooth and glossy.The catheter appeared cut as it could be due to removal of the device from patient.Although a definitive root cause could not be determined, improper placement technique could have potentially caused or contributed to the reported event.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: g4, h6 (patient code: 2058 - staphyloccus aureus).H11: h3, h6 (results, conclusion ).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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