Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: phaseal needles are designed to reduce the coring tendency.If coring comes from membrane: human error: performing multiple injections on the membrane could lead to fragmentation.Machines: if membrane is excessively welded, consistency is higher and elasticity lower, and once it is pierced by the needle, it could provoke membrane fragmentation.Materials: needles.If coring comes from rubber stopper: materials: rubber stopper.Quality of rubber stopper will impact the occurrence of particles.The larger the percentage of inorganic filler in the rubber stopper, the more often cores and fragments will be produced.Capping conditions have shown to have significant effect on coring tendency.The type of crimping device used as well as the sealing force will have an influence on coring.Materials: needles.Design and dimensions of the needle influence the tendency for coring, especially regarding the production of larger cores, cut out from the rubber stopper by the needle edges.Phaseal needles are designed to reduce occurrence of coring.Misuse by the user: if the user makes a bad connection or turn the protector on the cap of the vial rather than insert it vertically, the cannula of the protector because of the rubbing with the stopper of the vial may cause detachment of particles from the cap of the vial.It is recommended to carefully follow the instructions explained in the ifu.For every manufactured lot the laboratory technician made the particles fragmentation test according to the it-1730 procedure.The test is carried out within a in a laminate flow hood.Staff has to wear a lab coat, cap and gloves.As no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.A review of the device history record could not be completed for the incident lot as no samples were provided.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer's indicated failure mode.Root cause description: coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs.As several factors impact the coring tendency, a definite cause could not be determined for this incident.There were no changes in phaseal protectors recently.Use of the m12 assembly fixture is recommended to ensure proper connection of the protector to the vial.Rationale: complaints received for this device and defect will be closely monitored by our quality team and a corrective and preventive action plan has been initiated to prevent this defect from reoccurring.Prior to the investigation of this complaint a capa was open to assess coring tendency.
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