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 during placement, the foley catheter was naturally removed.There was probable damage in the balloon part.Per additional information via email from ibc on 15apr2024, it was stated that any damage in the balloon or any other part of the catheter was unknown and the pinhole in the catheter was unknown.
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