H10: the lot number of the returned device was provided and lot history review performed.It was observed that upon receipt of the device that the outer carton open and inner package seal is not intact.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10: b5, g4 h11: h6 (results 1, conclusion 1) 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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