The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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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The reported issue was unconfirmed.The root cause of the reported issue could not be determined.The reported issue was not replicated in depot repair.The issue was not confirmed, updates were made as a part of the service procedure.The sensica device was evaluated.The issue was not replicated in the depot service.The sensica device underwent service updates, new ground wire and optical sensor gasket foam was applied.Load cell was failed.Reported issue was not confirmed.Service updates were made per service procedure.The device worked correctly out of the box as well as after the load cell recalibration/final functional verification.The reported event is unconfirmed, dhr review is not required.The reported event is unconfirmed, labeling/packaging review is not required.Correction: d,h.H11: section a through f - the information provided by bd represents all 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.H3 other text : the actual/suspected device was inspected.
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