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 introducer needle was returned for evaluation.Gross visual, microscopic and functional testing were performed.The investigation is confirmed for the identified bent, reported needle fracture and leak issue as bend was noted on the needle and multiple cracks were observed on the proximal hub of the introducer needle and leaks were noted from the cracks on the hub upon infusion of the introducer needle.The definitive root cause could not be determined based upon 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: 05/2026).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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