H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 7fr hickman d/l catheter was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.A complete circumferential break was noted on the distal end of the catheter.However, striations were noted throughout the surface.The investigation is unconfirmed for the reported catheter fracture and confirmed for the reported fluid leak and identified burst issues, as a c-shaped break was noted approximately 1.2cm from the distal end of the bifurcate on the white luer.The edges of the c-shaped split on the white luer extension leg appeared jagged.Upon infusion of the white luer, a leak from the c-shaped split was noted.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: g3, h6 (device, method) h11: h6 (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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