This report has been identified as b.Braun internal report number (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.We received one used pencan 25gx3 1/2" (88mm) wint.-eu/ap/sa in open packaging.The following investigations were conducted: visual inspection: the received sample was taken to a visual inspection for damages according to the test method 102002 damages.Definition of the method: damages are visible changes in the original shape or surface of products and packaging caused by mechanical forces and/or manufacturing faults.Nominal: no damage is allowed that endangers the patient, impedes the use of the part as intended (e.G.The impairment of the function of a drop sensor), endangers the assembly or function of the component, impairs the appearance of the component.Actual: the used pencan cannula is broken off 69 mm from the cannula hub.The area of the break from the raw cannula shows that the cannula was bent before the break.The broken off part was not provided by the customer.Functional inspection: n.A.Physical inspection: afterwards, the outside diameter of the pencan cannula (several areas) was measured according to the drawing.The measured value (outside diameter) of the pencan cannula is within the specification.Because the measured value is within the specification and the sample was already used, we assume of a problem during the application process.Summary and assessment: based on the conducted investigations the tested sample is within the specification.Therefore, the complaint is considered as not confirmed.
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