The reported event was inconclusive.No sample was returned for evaluation.A potential root cause could be due to the ¿inadequate component (pump and relief valve) selection".The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the purewick urine collection system product ifus were found to be adequate based on past reviews.Correction: h5.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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