Model Number 328520 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/24/2023 |
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 the relion insulin syringes hub separated from the device.The following information was provided by the initial reporter: consumer reported found 1 syringe when removed needle shield from syringe needle hub assembly removed with shield and was stuck inside the shield.
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Manufacturer Narrative
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The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 09-jun-2023.H.6.Investigation summary: samples were received and an investigation was performed.This is the 1st 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 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 h10.
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Event Description
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It was reported that the relion insulin syringes hub separated from the device.The following information was provided by the initial reporter: consumer reported found 1 syringe when removed needle shield from syringe needle hub assembly removed with shield and was stuck inside the shield.
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Search Alerts/Recalls
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