In lieu of a reported lot number, a ship history report (shr) was generated for item number h965458110 in order to determine the last three lots shipped to the reporting customer in the six months prior to the procedure date.The three lots obtained through the shr were: (5251430, 5268494 and 5277747).The device history records for the lots obtained through the ship history report (packaging lots) were reviewed for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The recent angiodynamics complaint report was reviewed for the bioflo picc product family and the failure mode "aspiration difficulty - removed." no adverse trend was identified.The bioflo picc from the reported event was returned in eleven {11} pieces with bio material {blood} all over it.Each piece of catheter tubing and valve were occluded with bio material {blood clots} inside.After the cleaning process, no difficulty was noted when flushing each piece of catheter tubing and the valve.When the valve was visualized microscopically, the valve disc was confirmed to be slit and centered.There were no molding/manufacturing related non-conformances noted to the returned sample.The infusion and aspiration pressures were measured on the pasv valve and were found to meet specification.The catheter tip id and od were also measured and met specification.The reported complaint was unable to be confirmed, nor could an exact root cause be identified, as no manufacturing non-conformances were observed during sample evaluation.A potential root cause for the occlusion reported in the catheter tubing is care and maintenance of the picc device, i.E.Adequate flushing of device.This is discussed in the directions for use provided with the device.(pr (b)(4)).
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