The reported event was confirmed cause unknown.Visual evaluation of the returned sample noted one opened (without original packaging), unused irrigation bulb syringe.Visual inspection of the sample noted that there was a hair on the barrel.This does not meet the specification as "no hair is permitted on the product." a potential root cause for this failure could be defective / contaminated components from supplier¿.The lot number was unknown; therefore, the device history record could not be reviewed.Labeling review was not performed because labeling could not have prevented the reported failure.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.H3 other text : the actual/suspected device was inspected.
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