H10: the device reported in this event was previously captured in report 3006260740-2022-00228 with unknown product information.This report is sent to capture the now known product information and will be reported separately from 3006260740-2022-00228.H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 35cm hemostar d/l catheter was returned for evaluation.Gross visual, microscopic visual and functional evaluations were performed on the returned device.The investigation is confirmed for the reported material opacification issue as milky white opacification was noted on both the extension legs just proximal to the bifurcation.The investigation is also confirmed for the identified material protrusion and stretched issues as swelling was noted on both the extensions legs and further swelling was also noted on the catheter in the area between the bifurcation and the tissue cuff.Further, during functional evaluation, the both arterial and venous lumens were patent to infusion and aspiration without any issues.A definitive root cause could not be determined based upon the available information.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: d4(expiry date: 11/2021), g3, h6(device, method).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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