Catalog Number 301031 |
Device Problem
Particulates (1451)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/11/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device lot #: unknown.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 before use of the bd luer-lok¿ syringe there was a particulate within the syringe.There was no report of injury or medical intervention.
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Manufacturer Narrative
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A sample and photo were received by bd for investigation.The sample was evaluated and the reported defect of foreign matter was confirmed.The sample had a blue embedded dot in the plunger rod.A review of the device history record could not be performed as a lot number was not provided for this incident.Root cause is unknown.Bd was unable to identify the foreign matter in the plunger rod.No batch number was provided to investigate the batch it was produced in.
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Search Alerts/Recalls
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