The reported event was confirmed; however, the cause is unknown.A black speck on the bulb was measured to be (0.20 sq mm) which is below the aggregate total of 0.5sq mm and for the syringe the related cause is unknown since the black speck within the syringe was (0.40 sq mm) measuring below 0.5mm sq.According to the inspection procedure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Sec.801.116 medical devices having commonly known directions: a device shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual." product catalog number 0035280 is deemed by appropriate subject matter experts (sme) to be within this definition.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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