Catalog Number 383722 |
Device Problem
Fail-Safe Design Failure (1222)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/28/2018 |
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.
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Event Description
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It was reported that a nurse found that the safety activation failed on a bd pegasus¿ safety closed iv catheter system w/prn during use.There was no report of exposure, serious injury or medical intervention.
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Manufacturer Narrative
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Investigation summary: a photo was received for the purpose of our investigation.Bd was able to observe the reported failure mode in the sample provided.The supplied photograph shows that the v-clip was stuck in the tip shield, and that the v-clip was noticeably tilted.The tilted v-clip caused the inactivation of the unit.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 7054445.Investigation conclusion: the tilted v-clip caused the inactivation of the unit.Additionally our investigators have noted this lot was manufactured prior to a redesign was finalized that mitigates the occurrence of this type of failure mode.
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Search Alerts/Recalls
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