Catalog Number 328868 |
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 03/29/2023 |
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 200 bd ultra-fine¿ ii short needle insulin syringe label information was illegible.The following information was provided by the initial reporter: torn & information not clear.Additional information received 13 april 2023: observed there is double printed on product information on the packaging cause it difficult to read.As for torn packaging,.
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Manufacturer Narrative
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H6: investigation summary a complaint lot history check was performed on lot # 2255744 for package printing defect.This is the 1st related complaint for package printing defect on lot # 2255744.Investigation summary: no samples were returned therefore the investigation is performed based on the photos provided.The customer provided (2) photos of 0.5ml 30ga 8mm polybags, reporting packaging printing defect.The photos were visually examined and observed printing defect.Based on the photos provided, embecta was able to confirm the reported failure.A review of the device history record was completed for batch# 2255744.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the photos received, embecta was able to confirm the customer-indicated failure.
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Event Description
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It was reported that 200 bd ultra-fine¿ ii short needle insulin syringe label information was illegible.The following information was provided by the initial reporter: torn & information not clear additional information received 13 april 2023: observed there is double printed on product information on the packaging cause it difficult to read.As for torn packaging.
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Search Alerts/Recalls
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