Catalog Number 306547 |
Device Problem
Disconnection (1171)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/28/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that bd posiflush¿ normal saline syringe stopper disconnected from the plunger when aspirating.No serious injury or medical intervention was reported.
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Event Description
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It was reported that bd posiflush¿ normal saline syringe stopper disconnected from the plunger when aspirating.No serious injury or medical intervention was reported.
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Manufacturer Narrative
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Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.A device history review could not be completed as no batch number was provided.Investigation conclusion: based on no sample, the investigation concluded, bd was not able to verify the indicated failure.Root cause description: no root cause can be determined as no samples were received.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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