Catalog Number 391592 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/28/2021 |
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.(b)(4).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that venflon i 20ga 1.0 mm x 32mm catheter tip was damaged.This occurred on 5 occasions.The following information was provided by the initial reporter: catheter tip damaged found in venflon i 20g.
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Event Description
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It was reported that venflon i 20ga 1.0 mm x 32mm catheter tip was damaged.This occurred on 5 occasions.The following information was provided by the initial reporter: catheter tip damaged found in venflon i 20g.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/2/2021.H.6.Investigation: the samples were received by bd for evaluation.A quality engineer was able to review the returned (5) venflon 1 20ga from lot # 0210959 product # 391592 with the reported issue of ¿catheter tip damaged¿.The dhr was reviewed and no ncp or qn was raised on this lot during manufacturing and production of the lot number 0210959 until lot release.Customer returned samples and photograph are available for investigation.The team has investigated the samples and found the defect to be present on one of the samples.The defect is confirmed.The cannula tip was found to be bent and unevenly cut on one of the samples in the customer return samples.The investigating team has analyzed the complete process of the manufacturing on the machine and concluded that the probable root cause of the tip damage may have occurred during the process of reloading on va 35.Reloading of the components that fall off the conveyor are reloaded manually.This defect could be a one of case caused by human error due to manual intervention.
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Search Alerts/Recalls
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