The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be wrong product size selected, control panel circuiting problem, speed controller faulty, amplifier card faulty, drying parameters wrongly set, or incorrect material supplied.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 was unknown, the foley catheter ifus were found to be adequate based on past reviews.H11: section a through f - the information provided by bard 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 bard.H3 other text: the device was not returned.
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