Qn# (b)(4).The customer returned one sheath/dilator assembly with the dilator advanced into the sheath.The assembly was visually inspected and showed no obvious defects or anomalies.The outer diameter of the lower locking portion of the dilator hub was measured and did not meet specification.The inner diameter of the sheath valve cap, the dilator length, and the dilator body outer diameter were measured and found to be within specification.The dilator would not snap into the sheath hub and required little force to be removed.A device history record (dhr) review was performed with no relevant findings.The customer reported issue of the dilator and sheath not locking together was confirmed during the complaint investigation of the returned sample.The dilator would not fully snap into the sheath hub and required little force to be removed during functional testing.The outer diameter of the lower locking portion of the dilator hub measured out of tolerance during dimensional testing; therefore, the probable cause of this issue is manufacturing related.A capa was previously generated to further investigate this issue.
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