The reported issue was confirmed design related.The root cause of the reported issue is being investigated under capa.All good faith attempts have been made to obtain additional information.The outcome of the repair cannot be determined at this time.In the event that information regarding the outcome of the repair and the status of the device is received, this record will be reopened to update the investigation.The device did not meet specifications, and was influenced by the reported failure.It is unknown if the device was in use on a patient.The device history record review was not required as the complaint was addressed by existing capa.Labeling review was not required as the complaint was addressed by existing capa.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.
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