Model Number N/A |
Device Problem
Unsealed Device Packaging (1444)
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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.A lot history review (lhr) of rezc0751 showed (b)(4) other similar product complaint(s) from this lot number.The complaints for this lot number (reax1618) have been reported from the same (b)(4) facility.
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Event Description
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It was reported that the packaging was not completely sealed around the edge.Device was not used on patient.This reported addresses device forty.
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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 that the packaging was not completely sealed around the edge.Device was not used on patient.This reported addresses device forty.
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Search Alerts/Recalls
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