Catalog Number 1608062 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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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.The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of rebp0092 showed no other similar product complaint(s) from this lot number.
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Event Description
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It was reported to the sales rep by the physician at the facility that the peel away sheath would not break, this has occurred twice.This file addresses the initial occurrence.No reported patient harm.
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Manufacturer Narrative
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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.Initial medwatch was created in error.The device failure is exempt from mdr reporting per 21 crf803.19 reference (b)(4) and will be reported on alternative summary report.
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Event Description
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It was reported to the sales rep by the physician at the facility that the peel away sheath would not break, this has occurred twice.This file addresses the initial occurrence.No reported patient harm.
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Search Alerts/Recalls
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