(b)(4).The customer returned one fully intact peel-away sheath tab assembly.No extrusion or other components were returned.Definite signs of use were observed in the form of biological material on the distal portion of the tab assembly.Visual analysis revealed that there was no evidence of the sheath extrusion within the tab assembly mold.Microscopic examination confirmed this and confirmed that the tab assembly was fully intact.The tabs were manually pulled apart to further examine the assembly.The tabs separated smoothly with ease and did not reveal evidence of the sheath extrusion.The inner diameter of the tab assembly measured at 0.081".This result is expected as this is equal to the maximum tolerance of the sheath extrusion outer diameter (0.075"-0.081") per sheath extrusion product drawing.Note: the inner diameter of the tab molds may appear to be widened; this is due to inadvertent widening of the inner mold during dimensional analysis with pin gauges.Functional inspection was performed by manually pulling apart the tab assembly.The tabs were able to smoothly separate from each other with ease.A device history record review was performed, and a potentially relevant finding was identified.For part number eb-01041-002, three non-conformances were identified for the relevant batch (40014701, 40014843 and 40014920).The failure mode identified in these non-conformances is different than the observed failure mode for this complaint.The instructions for use (ifu) provided with this kit warns the user, "advance catheter, with stylet slowly through peel-away sheath to final indwelling position.Retract and/or gently flush while advancing catheter if resistance is met." the customer report of a broken peel away sheath tab was confirmed by visual inspection of the returned sample.The customer returned one fully intact peel-away sheath tab assembly.Visual analysis revealed that there was no evidence of the sheath extrusion within the tab assembly mold.Microscopic examination confirmed this and confirmed that the tab assembly was fully intact.The tabs were manually pulled apart to further examine the assembly.The tabs separated smoothly with ease and did not reveal evidence of the sheath extrusion.The tab assembly met all relevant dimensional and functional requirements.Based on the failure mode observed, manufacturing caused or contributed to the issue.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.
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