Catalog Number 393226 |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 06/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).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 that the bd venflon¿ pro safety peripheral safety iv catheter was inserted as usual.They used the venflon was subsequently found suitable for use of the procedure.After the ct scan they pulled out the venflon pro safety and discovered that the catheter was broken.They immediately scanned the patient and could see this piece of plastic in the patient's arm.Doctors from vascular surgery department were subsequently in correspondence and found no basis for further action.Found after use.No further information given at this time.
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Manufacturer Narrative
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Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.
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Event Description
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It was reported that the bd venflon pro safety peripheral safety iv catheter was inserted as usual.They used the venflon was subsequently found suitable for use of the procedure.After the ct scan they pulled out the venflon pro safety and discovered that the catheter was broken.They immediately scanned the patient and could see this piece of plastic in the patient's arm.Doctors from vascular surgery department were subsequently in correspondence and found no basis for further action.Found after use.No further information given at this time.
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Manufacturer Narrative
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Device returned to manufacture: yes.
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Event Description
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It was reported that the bd venflon pro safety peripheral safety iv catheter was inserted as usual.They used the venflon was subsequently found suitable for use of the procedure.After the ct scan they pulled out the venflon pro safety and discovered that the catheter was broken.They immediately scanned the patient and could see this piece of plastic in the patient's arm.Doctors from vascular surgery department were subsequently in correspondence and found no basis for further action.Found after use.No further information given at this time.
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Manufacturer Narrative
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Investigation summary: one actual sample, 8 representative samples and 2 photos were returned for the investigation of this complaint.Our quality engineer inspected the returned unit and confirmed the reported observation of a broken catheter.The manufacturing process was reviewed and 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.A device history record review was also performed and showed no non-conformance's associated with this issue during the production of this batch.Therefore, source of the defect could not be determined.A clean cut was observed on the broken catheter.The broken catheter could have probably been cut by sharp object.There is no process in the manufacturing facilities that could have caused this nonconformance.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.
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Event Description
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It was reported that the bd venflon¿ pro safety peripheral safety iv catheter was inserted as usual.They used the venflon was subsequently found suitable for use of the procedure.After the ct scan they pulled out the venflon pro safety and discovered that the catheter was broken.They immediately scanned the patient and could see this piece of plastic in the patient's arm.Doctors from vascular surgery department were subsequently in correspondence and found no basis for further action.Found after use.No further information given at this time.
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Search Alerts/Recalls
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