Catalog Number 928857 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/09/2023 |
Event Type
malfunction
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Event Description
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It was reported that the walgreens thin insulin syringe hub separated from the device.The following information was provided by the initial reporter: spouse reported, when consumer removed needle shield, needle and part that holds the needle got stuck in needle 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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Event Description
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It was reported that the walgreens thin insulin syringe hub separated from the device.The following information was provided by the initial reporter: spouse reported, when consumer removed needle shield, needle and part that holds the needle got stuck in needle shield.
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Manufacturer Narrative
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H6: investigation summary no samples (including photos) 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# (b)(4).All inspections and challenges were performed per the applicable operations qc specification.H3 other text : see h10.
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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: 05-oct-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.
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Event Description
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It was reported that the walgreens thin insulin syringe hub separated from the device.The following information was provided by the initial reporter: spouse reported, when consumer removed needle shield, needle and part that holds the needle got stuck in needle shield.
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Search Alerts/Recalls
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