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 on (b)(6) 2024, the kidney stone removal surgery was performed, and the product was found to be broken when the package was opened.It was a stent that was broken when user opened the package.The transparent plastic bag inside was opened and it was brand new and unused.
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