MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-01-23 for PLEXITRON TUR IRRIGATION SET ARC4002P manufactured by Baxter Healthcare - Cali.
[133887440]
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[133887441]
It was reported that the luer connector of a plexitron tur irrigation set was blocked. This was identified during set up at the clinic. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2018-08337 |
| MDR Report Key | 8271535 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-01-23 |
| Date of Report | 2019-02-20 |
| Date of Event | 2018-12-19 |
| Date Mfgr Received | 2019-02-06 |
| Device Manufacturer Date | 2018-10-04 |
| Date Added to Maude | 2019-01-23 |
| 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 Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - CALI |
| Manufacturer Street | CALLE 36 NO. 2C-22 APARTADO AERO 2446 |
| Manufacturer City | CALI |
| Manufacturer Country | CO |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLEXITRON TUR IRRIGATION SET |
| Generic Name | SYSTEM, IRRIGATION, UROLOGICAL |
| Product Code | LJH |
| Date Received | 2019-01-23 |
| Model Number | NA |
| Catalog Number | ARC4002P |
| Lot Number | SE18JA9 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - CALI |
| Manufacturer Address | CALI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-23 |