Catalog Number 328438 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/30/2023 |
Event Type
malfunction
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Event Description
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It was reported that the bd insulin syringe with the bd ultra-fine¿ needle hub separates from the device.2 of 2 related files.The following information was provided by the initial reporter: consumer reported found 2 syringes from this box needle shields hard to remove.When forced the shield off syringe the needle assembly stayed within the shield.
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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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Manufacturer Narrative
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The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 05-oct-2022.H.6: investigation summary: samples were received and an investigation was performed.This is the 2nd complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.H3 other text : see h.10.
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Event Description
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It was reported that the bd insulin syringe with the bd ultra-fine¿ needle hub separates from the device.1 of 2 related files.The following information was provided by the initial reporter: consumer reported found 2 syringes from this box needle shields hard to remove.When forced the shield off syringe the needle assembly stayed within the shield.
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Search Alerts/Recalls
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