The reported event was inconclusive because no sample was returned.It was unknown whether the device had met relevant specifications.The product was used for urine collection.It was unknown whether the product had caused the reported failure.The potential root cause for this failure mode could be due to mechanical failure, operator error, user related (eg: incorrect catheter size used).The lot number was unknown; therefore, the device history record could not be reviewed.Unable to review the labelling due to unknown product code.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.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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