Catalog Number 324917 |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/08/2023 |
Event Type
malfunction
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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 while bd insulin syringe with the bd ultra-fine¿ needle the tip is disconnected from the rest of the syringe.This is 2 of 2 reports.The following information was provided by the initial reporter, translated from portuguese: product was received and needles are broken in tip part, making impossible to use or sell it.The tip is disconnected from the rest of the syringe.The product was intended to be sold, there was no patient involvement and no medical procedure either.
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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 as broken barrel tip.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.
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Event Description
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It was reported that while bd insulin syringe with the bd ultra-fine¿ needle the tip is disconnected from the rest of the syringe.This is 2 of 2 reports.The following information was provided by the initial reporter, translated from portuguese: product was received and needles are broken in tip part, making impossible to use or sell it.The tip is disconnected from the rest of the syringe.The product was intended to be sold, there was no patient involvement and no medical procedure either.
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Search Alerts/Recalls
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