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.The initial complaint appeared to be a reportable occurrence.Upon further review it was determined that a reportable event had not occurred.Therefore, this event is deemed not reportable per 21 cfr part 803.A history review of serial number (b)(6) showed no other similar product complaint(s) from this serial number.
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