(b)(4).The report of a damage luer hub was confirmed through complaint investigation of the returned sample.The customer provided one image for analysis.Visual analysis revealed that the proximal end of the valve was damaged.The customer returned one, defective luer-activated valve for analysis.A white, powdery substance was noted on the outside surface.This substance appears consistent with medication and is an indication that the component was used.Visual analysis revealed that the proximal end of the valve was separated.The severed end was not returned for analysis.Microscopic examination confirmed the separation and revealed that the edges were jagged.White stress marks were also observed, which is damage consistent with a stress related break.Functional analysis could not be performed as part of this complaint investigation due to the severity of the damage.R & d unit indicated that a significant force would be required to create this damage as this component is made of sturdy plastic.Based on the appearance of the separation, undue force caused or contributed to this event.The ifu provided with the kit informs the user, "use only securely tightened luer-lock connections with any central venous access device to guard against inadvertent disconnection".The ifu also states, "connect all extension line(s) to appropriate luer-lock connector(s) as required.Unused port(s) may be 'locked' through luer-lock connector(s) using standard institutional policies and procedures".A device history record review was performed, and no relevant findings were identified.Based on the customer report, the sample received, and the comments from r & d, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
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