Model Number 328509 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2023 |
Event Type
malfunction
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Event Description
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It was reported that the relion insulin syringe hub separated from the device.The following information was provided by the initial reporter: consumer reported that the needle hub separated inside of the needle shield.
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Manufacturer Narrative
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B.3.Date of event: unknown.The date received by manufacturer has been used for this field.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: d10: device available for eval yes, d10: returned to manufacturer on: 08-may-2023.H6: investigation summary: customer returned (3) 0.5ml 31ga 8mm syringes in an open polybag from the lot# 1291230.It was reported that needle hub separated inside of the needle shield.Returned samples visually examined and observed needle hub separated for two syringes.A review of the device history record was completed for batch# 1291230.All inspections and challenges were performed per the applicable operations qc specifications.Embecta was able to confirm the customer indicated failure.H3 other text : see h10.
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Event Description
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It was reported that the relion insulin syringe hub separated from the device.The following information was provided by the initial reporter: consumer reported that the needle hub separated inside of the needle shield.
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Manufacturer Narrative
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H6: investigation summary no samples were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 1291230.All inspections and challenges were performed per the applicable operations qc specification.H3 other text : see h10.
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Event Description
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It was reported that the relion insulin syringe hub separated from the device.The following information was provided by the initial reporter: consumer reported that the needle hub separated inside of the needle shield.
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Search Alerts/Recalls
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