On (b)(6) 2021, a distributor of zyno medical reported a complaint.A user facility representative contacted the distributor on 01/27/2021 and stated that "an administration set model b2-70072 lot 20066195 set was dirty on the inside of the drip chamber".The medication being infused was vidaza.The device operator was a registered nurse.A patient was involved.The patient was not harmed.The user facility representative reported "it was the only set that we know of; when notified of it, all tubing on shelf was inspected, and all was good." "pt had fever yesterday and today.Was tested for covid (to rule that out- was negative).Vidaza day 3 & 4 held.Pt started on augmentin." the user facility representative also stated that "mixer and rn did not notice before (the infusion), only when disposed of, but they can't say with 100% accuracy." on 02/02/2021, the distributor provided additional information.The set did not have any other infusion done with another medication before this infusion.The rn did not see the particles in the drip chamber at the start of the infusion.It was only noticed after the infusion completed.The contract manufacturer of the affected device is becton, dickinson and company.
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The service provider provided the investigation report on 06/23/2021.The actual device was examined.The foreign particles are embedded degraded plastic material, which is soft pvc from the injection molding process.A batch review was performed on the affected lot.All the planned cleaning's of the plasticization group were done according to the scheduling.No anomalies were recorded.Complaint data was reviewed for one year period for model b2 70072.No additional complaints were found for the same failure mode.Based on the investigation results, no systemic cause was identified for this defect.Corrective actions were implemented to avoid similar cosmetic defects.
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