(b)(4).We received one catheter.Bbaj investigation result: visual inspection: the catheter has a cut 15mm from the tip.Surface of cut part has a damage which occurred when catheter was pulled from needle.(that is under the ban).Dimensions check: length: 1013mm, the outer diameter: cut part:0.17~1.02mm, damaged part:0.82~0.98mm, no damaged part:1.04mm (unused catheter the outer diameter:1.04mm length:920mm).Tensile strength test it is within the specification: result:8.9n (spec>5n).The occured failure is due to wrong handling by the end user.
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