The device history record (dhr) was reviewed and no deviations related to this failure mode were found.There were no non-conformances related to the reported issue.No trends or triggers were identified.The product sample consisted of one incomplete kit of product 36cm perm cath kit x5.The incomplete kit came inside a plastic bag and it presented signs of use.The kit was open and contained a catheter and sheath/dilator, oval.Visual inspection was performed and did not present any issue with the components of the kit that was returned.The returned sample was submitted to an underwater test.Both lumens (arterial and venous) extensions did not show bubbles during the test.Manufacturing performs 100% visual inspection per procedure and 100% leak testing per procedure; therefore a leakage would be detected during these processes.The device was returned and evaluated and no issues were found during visual inspection and functional testing.As per the instructions for use, it is necessary to perform a visual inspection before using the device.Do not use the catheter if it appears damaged or defective.The catheter tubing can tear when subjected to excessive force or rough edges.Inspect the catheter frequently for nicks scrapes, and cuts which could impair its performance.Do not use acetone on any part of the catheter.A leak could be caused due to excessive force, sharp objects or due to an inappropriate use of cleaning agents.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.
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