The reported event was confirmed however the cause was unknown.Visual evaluation of the returned sample noted one opened (without original packaging), unused silicone irrigation syringe.Visual inspection of the sample noted that there was a hole in between the barrel and the bulb.This does not meet the specification, "no hair is permitted on the product".A potential root cause for this failure could be "no follow up to the production areas cleaning procedure".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.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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