(b)(4).The customer returned one guide wire and one 3-lumen cvc catheter for evaluation.Visual examination of the guide wire revealed two kinks and a distorted j-tip.Visual examination of the catheter did not reveal any defects or anomalies.The guide wire contained two kinks at 208 and 242 mm from the proximal end.The length and outer diameter of the guide wire were measured and met specification.The length of the catheter body was also within specification.The returned catheter was advanced over the proximal tip of the returned guide wire in order to functionally test the components.The guide wire was able to advance through the catheter body but could not advance through the catheter juncture hub.When the guide wire was advanced from the distal extension lines it was able to fully pass through the catheter and out of the catheter distal tip.Because the returned guide wire was out of specifications, functional testing was done again using a lab inventory guide wire of the correct size.The lab inventory guide wire was unable to pass through the returned catheter.All 3 extension lines on the catheter were flushed with water and functioned as expected.No sign of blockage or inter lumen crossover was observed.A device history record review was performed with no relevant findings.(con't) other remarks: the reported complaint of difficulty passing the guide wire through the catheter was confirmed by complaint investigation.The returned guide wire was unable to pass through the returned catheter.Dimensional testing was performed, and it was determined that the returned guide wire did not meet specifications and its origin is unknown.Functional testing was again repeated with a lab inventory guide wire, which also failed.Visual examination revealed the guide wire contained two kinks.Based on the sample received, manufacturing caused or contributed to this event.A non-conformance request has been initiated to further investigate this issue.
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