Catalog Number 405122 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3.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 1500 of the bd quincke spinal needle experienced incorrect color on device.The following information was provided by the initial reporter: the colour of the hub for the current batch product has been changed , due to this the customers are not sure about the colour code of the product they, finding difficulties in identifying the product.
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Manufacturer Narrative
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H.6.Investigation summary: two photos were provided to our quality team for investigation.Through visual inspection, the hub is observed to be the correct color.A device history review was performed for lot 2303005, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.A change of the needle hub color was implemented and approved in (b)(6) 2022 for 25g needles to comply with iso 6009, changing the color from a more vibrant orange to be lighter as seen in the photo provided.Based on the sample evaluation and our quality team's investigation, no defect was observed on the product as the change in hub color was approved and implemented before the manufacturing of lot 2303005.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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Event Description
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It was reported that 1500 of the bd quincke spinal needle experienced incorrect color on device.The following information was provided by the initial reporter: the colour of the hub for the current batch product has been changed , due to this the customers are not sure about the colour code of the product they, finding difficulties in identifying the product.
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Search Alerts/Recalls
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