Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files could not be performed due to the unknown lot#.Based on the quality team's investigation, the root cause of this incident cannot be determined.Based on the verbatim, the neoflon pro product seem to be functioning as intended.
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It was reported that the neoflon pro 24ga 0.7mm od 19mm l caused extravasation and infiltration during use.The following information was provided by the initial reporter: "the physician complaint is that since they start using neoflon pro, they have more venipuncture attempts, the catheter blood chamber is not filling completely as before and it take more time for the blood visualization in the blood chamber.The main issue as they say is the instaflush, they have more infiltration and extravasation cases and in particularly with small neonates (500g).".
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