MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-30 for URO170816CN manufactured by Medline Industries Inc..
[145772127]
It was reported that the urinary catheter came out of the patient, with the balloon still inflated, after the clinician tugged on the device post-insertion. A new urinary catheter was inserted without further reported incident. No impact to the patient or the patient's stability was reported to the manufacturer. Reportedly, the urinary catheter involved in this incident was discarded. No sample was returned to the manufacturer for evaluation. A root cause for the reported product issue could not be determined. Due to the need for medical intervention to insert a new 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
[145772128]
It was reported that the urinary catheter came out and a new urinary catheter was required to be inserted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00057 |
| MDR Report Key | 8565029 |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-30 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-04-15 |
| Date Added to Maude | 2019-04-30 |
| 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 | 2249311457 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | TTL1LYR 16FR10ML 100%SILI C UM TRAY |
| Product Code | OHR |
| Date Received | 2019-04-30 |
| Catalog Number | URO170816CN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-04-30 |