Unknown manufacturer: (b)(4).Investigation summary: as no physical sample, material and/or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Capa is not required at this time.
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It was reported that unspecified bd¿ insyte catheter was damaged and separated, causing leakage.The following information was provided by the initial reporter: it is reported customer experienced separation, leaking, needle being too long and flimsy.Verbiage received, - iv equipment failure: iv becomes unhooked for the hub, bleeding from the site.Iv cannula and needle too long and flimsy at the 2nd iv start.Blood flash was undistinguished, and iv needed to be attempted 3 times before successful start.Adhesive window dressing has a slit which does not cover the connection between cannula hub and tubing extension, allowing it to become disconnected and bleeding from the iv site when pt was alone in the room.
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