The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to inappropriate snap fit.It was unknown whether the device had met specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The product catalog and lot number for this device was unknown.Therefore bd was unable to determine the associated labeling to review.Correction: e.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 device was not returned.
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