Catalog Number 328418 |
Device Problem
Break (1069)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 09/25/2023 |
Event Type
malfunction
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Event Description
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It was reported that the bd insulin syringes with bd ultra-fine¿ needle broke off.The following information was provided by the initial reporter: consumer reported found 1 syringe needle broke off in her arm.She was able to remove needle from arm herself.No medical attention needed.Caller denied reuse of needles.Long time diabetic.Item in her sharp's container.
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Manufacturer Narrative
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B.3.Date of event: unknown.The date received by manufacturer has been used for this field.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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Manufacturer Narrative
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H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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 the bd insulin syringes with bd ultra-fine¿ needle broke off.The following information was provided by the initial reporter: consumer reported found 1 syringe needle broke off in her arm.She was able to remove needle from arm herself.No medical attention needed.Caller denied reuse of needles.Long time diabetic.Item in her sharp's container.
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Search Alerts/Recalls
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