H.10.For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.The investigation is unconfirmed for the reported catheter bend and detachment issues.A root cause has not been determined.The device was labeled for single use.H11: b5: event; h6 (device code + description 1), h6 (results, 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.
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