It was reported that during use of an unspecified bd nexiva iv catheter samples hemolyzing.The following information was provided by the initial reporter: mat #unknown lot #unknown.It was reported by the customer that samples hemolyzing, iv's slipping out and placement being lost, iv sites blowing after clamping/unclamping, & tubing occluding on itself after clamping.Verbatim: mds-bd1- verbatim: iv blood draws are improving since last tutoring with company representative, but i am still having to redraw about 25% of the patients that i draw off one of these new iv's.I hear from many other nurses that they experience similar and other issues, or i would not bother refiling a pearl regarding these iv's.We like that they are sealed against blood but issues i hear start with samples hemolyzing and range from the iv's slipping out easily and placement being lost, to iv sites blowing after clamping/unclamping, to tubing occluding on itself after clamping, to aprn/crna's refusing to even use them.
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There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: as no physical sample, valid part number 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.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.
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