The event is reported at this time based on analysis results which indicated a reportable event.H3.Product analysis: equipment used: vis (m-81805), 203cm ruler (m-83361) as found condition (condition of returned device): an echelon-10 micro catheter was returned for analysis within a shipping box; within a sealed biohazard pouch and within a sealed tyvek pouch.Visual inspection/damage location details: the echelon-10 total length was measured to be ~154.8cm.The echelon-10 useable length was measured to be ~146.9cm.Upon visual examination, no issues were found with the echelon-10 hub; however, what appeared to be saline residue was found within hub.The echelon-10 catheter body was found to be kinked at ~118.3cm from distal end.The distal marker band and distal tip were found to be separated and not returned.The tubing material of the catheter separated end exhibited stretching with jagged edges.No other anomalies were observed.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿prod damaged/deformed out of pkg¿ was confirmed; however, the broken end of the catheter exhibited plastic deformation (stretching and jagged edges) which indicate that the catheter separated when exceeding the tensile strength of the tubing material.A formal investigation regarding this issue was previously conducted.Based on the formal investigation, potential sources of this issue are either improper product packaging, during manufacturing or improper removal of the product from packaging by the end user.However, the cause for the damage could not be determined.Based on the reported information and the device analysis the customer¿s report of ¿catheter kink/damage¿ was able to be confirmed; however, the root cause was unable to be determined.Possible cause for ¿catheter kink/damage¿ is delivery system removed aggressively.If information is provided in the future, a supplemental report will be issued.
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