The reported event is confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.Photo samples of the packaging of a bipolar pacing electrode catheter were returned.The photos showed the packaging of the sample was open near the top of the packaging.As the cause of the packaging opening is unknown, the reported event will be confirmed cause unknown.It is unknown whether the device had met relevant specifications.The device was unused, but is intended for diagnostic and treatment purposes.A potential root cause for this failure mode could be, "inadequate packaging design".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required as review of the label would not have prevented the reported event.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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