H.6 investigation summary : a clinical practice consultant (cpc) site visit and investigation from the area bd disposables sales and clinical consultant to michigan medicine was done due to ongoing complaints of disposable concerns including syringe tips breaking off inside of extension set me2017 or within stopcocks, in addition to tubing leaks, cracks or crumbling of the fixed collar on the distal end of extension set me2017.Findings from the site visit determined that there is most likely a correlation to the usage of alcohol products (in the form of tips) and the incidences of cracked, broken or crumbled fixed collars on make luer end of set me2017.If proper dry times are not followed after scrubbing the hub, alcohol binding may result causing the reported failure modes.With the continued use of alcohol products; bd has proposed alternate products that will have improved product performance.The improved chemical resistance, including alcohol resistance, is due to the materials used in manufacturing the male and female luers.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.H3 other text : see h.10.
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