The reported device was received with original unopened product packaging.Label verification and visual examination were performed.The device was observed to have a tear in the packagings poly material.Due to the location and appearance of the defect area, it is likely that the device caused the damage to the packaging.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of this product.The products released for distribution were found to have met all specifications prior to shipment.Of the lot containing (b)(4) units, only one other complaint for this lot number and failure mode has occurred.A two-year review of complaint history revealed 3 similar complaints for a total of 13 devices.During this same time frame, (b)(4) devices have been manufactured and shipped worldwide.Should all devices have been confirmed this would make the rate of occurrence of this failure (b)(4).This reported packaging issue was obvious to the distributor, prompting the return of the device for evaluation.There was no patient involvement.As with all medical devices, examination of the product occurs multiple times prior to use.Good clinical practice would include examination and verification of the original packaging and its labeling to ensure both are intact.This issue will continue to be monitored through the complaint system to assure patient safety.
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