Catalog Number 393206 |
Device Problem
Break (1069)
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Patient Problem
Injury (2348)
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Event Date 08/31/2017 |
Event Type
Injury
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Manufacturer Narrative
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A sample is not available for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.Photos were obtained, upon completion of the investigation, a supplemental report will be filed.Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.(b)(4).
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Event Description
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It was reported that during the removal of the 1.3mm x 32mm bd venflon¿ pro safety shielded iv catheter, the nurse noticed that the cannula was broken three mm after the hub.X ray showed the cannula in the arm.Surgeon cut the skin, opened the vein and removed the cannula.Sutured the vein with prolene 6.0 and different skin layers.The patient had the cannula surgically removed.
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Manufacturer Narrative
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Investigation: six photos were returned for the investigation of this complaint.Photos returned: there is no photo of the cannula.Broken catheter was observed on the returned photos.The broken catheter could have probably been cut by sharp object.The manufacturing process was reviewed.There is no process in the manufacturing facilities that could have caused this nonconformance.The manufacturing process includes an automated vision inspection machine that will reject parts not meeting lie distance requirement.A broken catheter will automatically be rejected as the lie distance will be out of specification the broken catheter could have probably been cut by sharp object.Therefore, this reported nonconformance could have occurred out of the manufacturing facilities.There is no process in the manufacturing facilities that could have caused this nonconformance.
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Search Alerts/Recalls
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