Catalog Number 328519 |
Device Problems
Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/14/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.No lot # provided.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that a bd insulin syringe with the bd ultra-fine¿ needle 1ml 31g (6mm) malfunctioned before use as the syringe needle broke off into the vial.There was no report of injury or medical intervention needed.
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Manufacturer Narrative
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Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.Unable to perform dhr check due to unknown lot number.Based on the samples / photo(s) received the investigation concluded: - unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.Investigation conclusion: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.
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Search Alerts/Recalls
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