Catalog Number 309657 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.No lot # provided.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that during use a bd luer-lok¿ disposable syringe with bd luer-lok¿ tip was found with difficult plunger movement as ¿customer reports that after filling her syringe with insulin, she was not able to push on the plunger to release the insulin.Customer couldn't get the insulin out of syringe.¿ there was no report of exposure, injury or medical intervention needed.
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Manufacturer Narrative
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Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.No root cause can be determined as no samples were received.Based on the fact that no defect was found, capa is not required at this time.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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