It was reported that prior to use, when the staff selected the 4.0x20 mm nc trek balloon dilatation catheter (bdc) box, the box was slightly torn and a used device was inside.The balloon was bloody and the pouch was opened.The device was not used (in this procedure) and there was no patient involvement.A new device was used to complete the procedure.There was no reported clinically significant delay in the procedure.No additional information was provided.
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The device and complaint component (packaging) were not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported complaints.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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