ANGIODYNAMICS ANGIODYNAMICS / BIO FLO; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number H965440140 |
Device Problem
Occlusion Within Device (1423)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/02/2016 |
Event Type
malfunction
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Manufacturer Narrative
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As no lot number was provided, a ship history report (shr) was generated for item number (h965440140) in order to ascertain the last three lots shipped to the reporting hospital in the six months prior to the procedure date.The device history records for the lots obtained through the shr were reviewed for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The march 2016 angiodynamics complaint report was reviewed for the bioflo ports product family and the failure mode "occluded - removed." no adverse trend was indicated.The reported complaint description cannot be confirmed, nor can a root cause be identified, as no sample was returned for evaluation.Angiodynamics process controls in place for this device include 100% aspiration of port valve assemblies at qa incoming.Valve assemblies are then sent back to supplier to be assembled into ports.Pasv valve crack testing: valves are 100% tested for aspiration pressure prior to being assembled into port bodies, and port 100% hydrostatic air test (hat): valves are 100% tested for infusion pressure after being assembled to port bodies.
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Event Description
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Patient had a bioflo port placed less than a year ago.He responded well to his chemo, had completed his therapy, and was currently just maintaining the port.The infusion nurses were not able to flush it (occluded with an obvious clot), so they decided to send him back to dr.(b)(6) for the removal.
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