Catalog Number 328519 |
Device Problems
Detachment Of Device Component (1104); Material Fragmentation (1261)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/11/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.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 needle of a bd insulin syringe with the bd ultra-fine¿ needle detached and remained in the patients arm.He was able to remove the needle with his fingers and there was no report of injury or medical interventions.
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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.A review of the device history record was completed for batch # 7037944.All inspections and challenges were performed per the applicable operations qc specification.There was one notification (b)(4) noted that did not pertain to the complaint.Severity: occurrence: a complaint history check was performed and this is the 1st related complaint for needle break off in use, the 1st related complaint for hub damaged and the 1st related complaint for needle separates in vial on lot # 7037944.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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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