Model Number 405081 |
Device Problem
Material Discolored (1170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd¿ spinal needle with quincke bevel experienced incorrect color on the device.The following information was provided by the initial reporter: color of hub has a dark grey which is usually light gray.The number of cases found 1 box.
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Manufacturer Narrative
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Initial reporter addr1: (b)(6).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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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 17-jan-2023.H6.Investigation summary: photo samples was provided to our quality team for investigation.The photos display the material information as reported, and the photos comply with the specification to color, however, we are not able to confirm the indicated failures therefore we cannot verify the reported issue.A device history review was performed for the reported lot 2129539 and no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Inspections were performed according to procedure and had satisfactory results, product met required specifications for release.Based on our investigation, we cannot identify a definitive root cause at this time.
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Event Description
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It was reported that the bd¿ spinal needle with quincke bevel experienced incorrect color on the device.The following information was provided by the initial reporter: color of hub has a dark grey which is usually light gray.The number of cases found 1 box.
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Search Alerts/Recalls
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