Catalog Number 328506 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/22/2017 |
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.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 during use of the bd relion® insulin syringe the consumer reported that three needles separated from the syringes; one stayed in the vial and two lodged in his abdomen after injection.He removed them with tweezers.There was no report of injury or medical intervention.
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Manufacturer Narrative
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Investigation results: investigation summary: no samples (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# 7177611.All inspections and challenges were performed per the applicable operations qc specifications.There were four (4) notifications (b)(4) noted that did not pertain to the complaint.Severity: s_2__; occurrence: a complaint history check was performed and this is the 2nd related complaint for needle breaks off in use on lot # 7177611.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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