MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-26 for URO170816 manufactured by Medline Industries Inc..
[139986716]
It was reported that a patient noted that she felt wet approximately fifteen (15) minutes after the urinary catheter was inserted. Reportedly, a staff member assessed the patient and noted that the pad underneath her was wet with urine. The staff member believed that urine was leaking from the urinary catheter's shaft. The urinary catheter was removed by the staff member and a new urinary catheter was inserted without further reported incident. No impact to the patient's stability or need for additional medical intervention and/or follow-up care was reported to the manufacturer. The urinary catheter involved in the reported incident was returned to the manufacturer for evaluation. Visual inspection of the urinary catheter revealed no defects or abnormalities. Functional inspection was performed by inflating the urinary catheter balloon with 10ml of water. The urinary catheter balloon inflated and deflated fully with no defects, abnormalities, or leakage noted. Water was then passed through the urinary catheter's eyelets and allowed to drain into the urine meter. All water was able to drain properly into the urine meter, with no defects to the urinary catheter noted or leakage identified. The reported product issue was not confirmed and a root cause for the reported incident could not be determined. Due to the need for medical intervention to remove and replace the urinary catheter, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[139986737]
It was reported that the urinary catheter was leaking. The urinary catheter was removed and replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00038 |
| MDR Report Key | 8453785 |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-03-21 |
| Date Added to Maude | 2019-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 600932753 |
| Manufacturer Country | US |
| Manufacturer Postal | 600932753 |
| Manufacturer Phone | 2249311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | TTL1LYR 16FR10ML 100%SILI UM TRAY |
| Product Code | OHR |
| Date Received | 2019-03-26 |
| Returned To Mfg | 2019-03-22 |
| Catalog Number | URO170816 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-26 |