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 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.
|
It was reported that there was a regular problem with bard foley catheters for a while within the intensive care department.Stated that they were not draining properly (batch# unk) or were clogged (batch # unk) and therefore the patients got a full bladder.Last week, a patient who had 1300 cc in the bladder and had a catheter, when removed the balloon looked a bit strange (batch# unk).It went well for a while, but last fall they also had three patients (batch# unk) per follow-up information received from ibc on (b)(6) 2023, stated that the balloon looked a bit strange meant that the balloon looked adhered and was also bloody but that could also be from the patient.For this case, they had now seen only one patient but the lot number could not be traced.As for the catheters that were not draining properly, they did not know the lot number or the number of patients that had this issue.However, they often had to siphon to empty the bladder properly, could be due to the catheter but also the urimeter.As for the catheters that were clogged, they did not had any idea about the lot number or the number of patients that had this issue.As for the previous problems, none were reported except for one that was.In that patient, it was typical that they did urinate 30-40 cc, but had abdominal pain.They took out the catheter and at that point the urine poured out and the abdominal pain disappeared.No medical intervention was reported.
|