The reported event was inconclusive.No sample was returned for evaluation.The potential root cause for this reported event could be due to bacterial infection, long indwelling time, surface irregularities.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "single use only.Do not resterilize, for urological use only." correction: b.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.
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