This report has been identified as b.Braun medical inc.Internal report # (b)(4).Two used extension sets were received for eval.Packaging returned with both sets indicated the reported lot number # 0061394026.One package was labeled "right"; the other package was labeled "made wrong".No visual differences were noted between the samples.The spin-lock collar on the t-port luer lock endings were connected to a female luer by fully rotating the collar.Both sets were then subjected to an air pressure (leakage) test according to specification with acceptable results.There were no leakages observed from the luer lock ending or from any other location on the sets.The diameters of the spin-lock collar and luer port were dimensionally measured according to specification and found acceptable on both samples.In addition, the luer connectors on the sets met the applicable iso luer gauge specification.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported events.The returned samples met specification, and the reported failure could not be reproduced.If additional pertinent info becomes available, a follow-up report will be filed.
|