Catalog Number 309657 |
Device Problems
Retraction Problem (1536); Aspiration Issue (2883)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.No lot # provided.Medical device expiration date: unknown.Device manufacture date: unknown.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 with the use of the bd luer-lok¿ disposable syringe with bd luer-lok¿ tip there was an issue with difficult plunger movement.It was stated ¿the customer pulls back on the plunger but is unable to stop it at less than 3ml.Customer is unable to fill the syringe with less than 300 units.When the plunger was completely pulled out, it would not go back to it's original place.¿ there was no report of injury or further medical intervention.
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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.No root cause can be determined as no samples were received.No device history record review can be completed as lot number was not provided.If samples or additional information is received from customer, complaint will be reopened and further investigation will be performed.No capa is required as no defect could be confirmed.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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