Catalog Number 328421 |
Device Problem
Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/30/2023 |
Event Type
malfunction
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Event Description
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It was reported that the bd insulin syringe with bd ultra-fine¿ needle's syringe was punctured from the needle cap.The following was translated from chinese to english: complained that the syringe was punctured from the needle cap and injured the customer.
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Manufacturer Narrative
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H.3.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 bd insulin syringe with bd ultra-fine¿ needle's syringe was punctured from the needle cap.The following was translated from chinese to english: complained that the syringe was punctured from the needle cap and injured the customer.
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Manufacturer Narrative
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H.6.Investigation summary: no samples were returned therefore the investigation was performed based on the photo(s) provided.Embecta was able to confirm the customer-indicated issue.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.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.H3 other text : see h.10.
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Search Alerts/Recalls
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