The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "material surface is rough, abrasive or uncomfortable".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number and lot number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.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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