H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one bard magnum biopsy needle was returned for evaluation.During visual evaluation, the device appeared to have blood residue.On further evaluation, it was noted that sample notch appeared to be bent.Upon dimensional observation, sample notch thickness was within the specification and sample notch bend was not within the specification.Functional testing was not performed due to the condition of the device.Therefore, the investigation is confirmed for the reported bent needle issue, as the sample notch appeared to be bent.However, the investigation is inconclusive for the reported difficult to remove issue, as the reported conditions of use could not be replicated.A definitive root cause for the alleged bent needle and difficult to remove 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.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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