Catalog Number 328521 |
Device Problems
Air Leak (1008); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/27/2018 |
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.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 before use of the bd relion® insulin syringe the ¿consumer reported air bubbles in her syringe and also one syringe with something on the needle appearing to be plastic or glue.Consumer does not re-use.¿ there was no report of medical intervention.
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Manufacturer Narrative
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Customer only returned a shelf carton and an open, empty poly bag from lot # 7037606.No syringes (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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# 7037606.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200684932] noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for air bubbles and the 2nd related complaint for foreign matter on needle on lot # 7037606.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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