The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be user related (example: salt accumulation)/block drainage lumen/no drainage eye.) the device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Unable to review the labelling due to unknown product code.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.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.H3 other text : the device was not returned.
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It was reported that there was no urine drained after using the indwelling catheter, leading to urinary retention in the patient.Immediate emergency treatment by clinicians was required.It was unknown what medical intervention was provided.Per follow-up information received from ibc on (b)(6) 2023, stated that the patient did not had any immediate emergency treatment or any medical intervention.
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