The reported event was confirmed.The product was not used for treatment purposes as it was unused, and was not within specification and was influenced by the failure.Visual evaluation of the sample noted one opened (without original packaging) irrigation bulb syringe with a piece of tape attached.It was noted that there was a 0.9115" long hair between the barrel and bulb.No hair is permitted on the product.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be defective / contaminated components from supplier.The lot number is unknown therefore the device history record could not be reviewed.A labeling review was not performed because the user could not have caused the reported issue so labeling does not apply.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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