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 denali filter kit was returned for evaluation.Following components were received: introducer sheath, and a dilator.The dilator arrived loaded into the introducer sheath.The introducer sheath appeared to have a complete circumferential break approximately distal to the introducer radiopaque marker band.No functional testing was performed.Therefore, the investigation is confirmed for the reported break and the identified deformation due to compressive stress issues as the circumferential break was noted to the introducer sheath and the distal tip was deformed.A definitive root cause for the reported break and identified deformation due to compressive stress issue could not be determined based upon the provided 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: 11/2022), g3, h6(method).H11: b5, h1, h6(patient, device, result, 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.H3 other text : see h10.
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