Catalog Number 326666 |
Device Problem
Material Separation (1562)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/23/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that the needle shield on a bd ultra-fine¿ insulin syringe separated.No serious injury or medical intervention was reported.
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Manufacturer Narrative
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Investigation summary: customer returned photos of a 1/2cc syringe.Customer states that the needle shield was detached.The attached photos were examined and exhibited the syringe with the hub-needle/shield assembly separated from the barrel.No damage to the barrel was observed.Capa 97451 has been opened to address this issue.Severity: s_1__; occurrence: unable to perform complaint lot history check due to unknown lot number.Unable to perform complaint lot history check due to unknown lot number.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.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.Based on the above, no additional investigation is required at this time.
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Event Description
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It was reported that the needle shield on a bd ultra-fine¿ insulin syringe separated.No serious injury or medical intervention was reported.
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Search Alerts/Recalls
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