Catalog Number 256057 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported while opening pouch with bd veritor(tm) sys for rapid detection of group a strep the tube was broken and leaking.There was no report of user impact.
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Event Description
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It was reported while opening pouch with bd veritor(tm) sys for rapid detection of group a strep the tube was broken and leaking.There was no report of user impact.
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Manufacturer Narrative
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After further evaluation of the complaint, it has been determined that the previously submitted mfr report# 3006948883-2021-00155 was sent in error.Physical defect when tubes are broken is not considered to be a reportable malfunction.
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Search Alerts/Recalls
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