MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-26 for URO180814 manufactured by Medline Industries Inc..
[140003207]
It was reported that a patient required a foley catheter exchange after it was noted that urine was leaking from the vent material of the urine-meter drainage system. Reportedly, the incident was noted within less than 24 hours of the foley catheter being placed in the patient. The foley catheter was discontinued and a new foley catheter system was inserted. There was no reported impact to the patient. There was no serious injury or follow-up care reported related to the event. Due to the reported event and need for foley catheter re-insertion, this medwatch is being filed. The reported issue of a leaking vent was verified through functional evaluation of the received sample. There is no definitive root cause for the leakage at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[140003208]
It was reported that patient required a foley catheter exchange after it was noted that urine was leaking through the vent material of the urine meter drainage system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2019-00040 |
| MDR Report Key | 8451587 |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-01 |
| Date of Event | 2019-02-23 |
| Date Mfgr Received | 2019-03-01 |
| 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 | BERMON PUNZALAN |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | TTLVENT 14FR10ML 100%SIL UM TR |
| Product Code | OHR |
| Date Received | 2019-03-26 |
| Returned To Mfg | 2019-03-07 |
| Catalog Number | URO180814 |
| Lot Number | UNK |
| 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 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-26 |