It was reported that foley catheter balloon unable to deflate.Per additional information received on 27mar2024, stated that product was used on a patient and no harm on patient.Per follow up response via email on 27mar2024, stated that product was used on at least 2 patients.Defect noticed when attempted to remove foley was unsuccessful due to balloon not deflating.Patients were fine.In both events, the port had to be cut in order to drain out fluid.
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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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