H10: manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the delivery system was returned for evaluation and the broken piece of the proximal luer port was still attached to a syringe loaded with fluid which leads to confirmed results for a break.It was reported that the part broke off while the customer was flushing the device.Based on the evaluation of the returned sample, the investigation is closed with confirmed results for break.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use sufficiently address the potential risks.With regards to preparation, the instructions for use states: "attach the syringe to the luer port at the back of the endovascular system and flush the endovascular system until saline leaks from the distal tip of the catheter" and "carefully remove the endovascular system from its packaging and inspect packaging and system for any damage or defects".H10: d4 (expiry date: 08/2024), g3.H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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