The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The device was manufactured on 18-apr-2021.One sample was received at the manufacturing site for the investigation.The affected component is purchased from an external supplier.A complaint notification was sent to the supplier along with the sample to initiate the investigation.Per the supplier, the reported issue of balloon burst was confirmed.Upon evaluation, the balloon was verified having a tear that prevented the device from functioning as intended.Through a physical inspection using a microscope, lighted magnifying glass, and unaided eye, the entire device looked in a good functional condition besides the balloon damage.It was apparent the device was used but the duration of the usage was not provided.When a device is used, the balloon cuff has discoloration and expanded to the extent the balloon cuff will not return to its normal unused condition.Knowing this detail, the unit seemed to have functioned as intended prior to the reported issue.No other issue was observed to be abnormal that would have induced the reported issue.There are other factors that affect product performance which include device handling, packaging, shipping, storage, cleaning, and maintenance.Additional possibilities that affect balloon life include unique patient factors such as diagnosis, treatment, surgical procedures, as well as medications, nutrition formulas, and gastric ph.Instruction for use (ifu) shall be followed for optimal performance.These devices are not considered permanent and shall be cared for and replaced as needed.Each unit is tested 100% throughout multiple stages of the manufacturing process including a 100% balloon inflation test for a minimum duration to ensure product integrity and functional performance.That testing would identify any issues during the process which limits latent issues in the field when the product is used.All devices were tested and released as conforming at the time of the lot manufacturing.Based on the investigation performed, it was not possible to determine the definitive root cause of the reported issue.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.
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