Model Number N/A |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Patient Involvement (2645)
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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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rezc0751 showed 41 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 report addresses device two.
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Manufacturer Narrative
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The initial complaint appeared to be a reportable occurrence.Once sample was received and evaluated the evidence showed that the package was sealed properly.It is unknown when or how the packages became open.Therefore, it has been determined that a reportable event had not occurred per 21 crf803.19.
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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 address device two.
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Search Alerts/Recalls
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