(b)(4).The customer returned one 2-lumen picc for evaluation.Visual examination revealed the distal luer was separated from the extension line.Microscopic examination revealed remnants of extension line extrusion remained within the luer.This defect is consistent with a molding issue.The total length of the catheter body measured to be 16.0" which is within specifications of 15.875-16.063" per product drawing.The outer diameter of the distal extension line measured 0.09565", which is within specifications of 0.093-0.097" per distal extension line extrusion graphic.The inner diameter of the distal extension line measured 0.058", which is within specifications of 0.055-0.059" per distal extension line extrusion graphic.The proximal lumen was flushed with no blockages or leaks detected.A manual tug test confirmed the proximal lumen was fully secured within the luer hub.A device history record review was performed with no relevant findings.The instructions-for-use provided with this kit warns the user, "do not apply excessive force in placing or removing catheter.Excessive force can cause catheter breakage.If placement or withdrawal cannot be easily accomplished, an x-ray should be obtained and further consultation requested.Do not secure, staple, and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the customer report of a separated luer hub was confirmed by complaint investigation of the returned sample.The distal luer hub was separated from the lumen and contained damage consistent with a molding issue.A device history record review was performed with no relevant findings.Based on the sample received, manufacturing (molding) caused or contributed to this event.A non-conformance request has been initiated to further investigate this issue.
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