The reported event was confirmed.Visual inspection of the sample noted a loose hair trapped between the bulb and syringe, that extended along the outside face of the bulb.This was out of specification.A potential root cause for this failure could be 'no follow up to production areas cleaning procedure'.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate.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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