A visual inspection was performed on the returned device.The reported complaint was unable to confirmed or replicated in a testing environment as it was based on operational circumstances.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history revealed no other similar incidents.The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure.Based on the reported information, it is likely that the technique used to open the pouch was too fast and/or was pulled apart roughly resulting in the pouch opening to quickly causing the tear on the pouch and the device falling to the ground.Additionally, based on the returned analysis of the pouch, no anomalies were noted on the vendor or abbott seals.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
|