The device history record file was reviewed, and no discrepancy was found that could lead to the reported condition.One sample was received for evaluation.After performing an inspection of the sample, the condition reported as ¿difficult to remove rod from catheter¿ is confirmed.Because the catheter tip is a molded insert, it is possible that during tip forming, the catheter hole has exceeded the heating exposure causing the catheter to dry up with the assembled rod, which affected the rod tip size, causing the device to become difficult to remove.To avoid the thermal contractions of the catheter when the material is malleable, an additional process step requires the insertion and removal of the rod from catheter for all assembled units of the lot after the forming of the catheter tip was included as part of the standard work instruction to ensure the correct insert and removal from the rod.Based on a gemba walkthrough, the manufacturing process was reviewed and verified that all process and controls were followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.In addition, quality control inspections are performed on the product for material release.Production personnel perform a 100% visual inspection during the packaging process to detect and discard any identified non-conforming product.
|