Submit date: (b)(6) 2016.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A sample was received for evaluation.A visual inspection was performed and the infusion adapter port was detached from the infusion lumen.The outside diameter of the tubing and inside diameter of the adapter was measured.Both were within specifications.Glue residue was not found inside the adapter.A possible root cause can be due to an incorrect position of the tubing in the mandrel may affect the glue application through the clear adapter.As per the instructions for use, it is necessary to perform an inspection before using the device.Do not use the catheter if it is crushed, cracked, cut, or otherwise damaged.Do not infuse against a closed clamp or forcibly infuse a blocked catheter: backpressure could force the adapter out of the tubing.Do not infuse against a closed clamp or forcibly infuse a blocked catheter: back pressure could force the adapter out of the tubing.A quality alert was performed to the personnel involved in order to avoid this issue in the future.This event will be handled through a formal corrective and preventative action and no further actions are required.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 non-conforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.
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