The reported event is unconfirmed as the reported problem could not be reproduced.The used temporary pacing electrode with attached luer syringe was returned with the original packaging.The device was used for treatment purposes.The device had met relevant specifications.No root cause was required as the reported event is unconfirmed.As the reported event is unconfirmed, a dhr review is not required.As the reported event is unconfirmed, a labeling review is not required.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 actual/suspected device was evaluated.
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