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 the customer opened the ureteral stent package.After opening the sterile package, they found that the tail of the stent was broken.For inspection purposes, open the inner packaging of the stent and take out the stent, the stent was individually wrapped in plastic.Since the tail end of the stent was broken, they complained that the detached tail end was not retained.Per additional information via email from ibc on 08apr2024, the product was not used on patients and patients were not affected.
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