The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided 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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It was reported that when the ureteral stent was opened, it was found that the stent tube was broken and could not be used.The package had been unpacked and the stent had broken before the silk thread was cut.However, the operating room nurse still took out the stent and cut the silk thread with scissors.The sample had been processed by the nurse and could not be returned.The clinicians would be sent a new set of ureteral stents.
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