The reported event was inconclusive.No sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was not used for diagnostic or treatment purposes, as it was no used on a patient.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be ¿contaminants, latex defects or abrasion of balloon after attachment to shaft".The lot number was unknown; therefore, the device history record could not be reviewed.Labeling review was not required as the reported event is unlikely to be caused by the user.Correction: h.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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