Catalog Number 383914 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
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Event Description
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It was reported that there was a safety shield activation failure of a bd pegasus¿ safety closed iv catheter system.There was no report of exposure, 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.The investigators were able to observe the reported failure mode in the sample provided.Unfortunately the positioning of the v-clip could not be observed in the photo provided.A review of the device history record could not be performed as a lot number was not provided for this incident.Investigation conclusion: although the root cause could not be finalized without visually observing the positioning of the v-clip, previous investigations the most likely root cause of this failure mode is related to a tilted v-clip that caused inactivation of the device.
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Search Alerts/Recalls
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