Catalog Number 309580 |
Device Problems
Out-Of-Box Failure (2311); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The customer's name and address is unknown.(b)(6) has been used as a default.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 that foreign matter described as a ¿black flake¿ was found in a bd luer-lok¿ syringe with attached needle before use.There was no report of exposure injury or medical interventions.
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Manufacturer Narrative
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Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Dhr review for batch 7268850 (p/n 309580): manufacturing dates: 10/28/2017 to 10/29/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 6357991 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Investigation conclusion: no root cause can be determined as no samples were received.
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Search Alerts/Recalls
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