H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one introducer needle was returned for evaluation.Gross visual, microscopic and functional testing were performed on the returned device.The investigation is confirmed for the reported needle damage issue as cracks were noted on the introducer needle hub and upon infusion, leaks from the hub were observed.However the investigation is inconclusive for the reported aspiration issue as the exact circumstances at the time of the reported event was unknown.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.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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