MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-09-07 for TUR IRRIGATION SET 2C4005 manufactured by Baxter Healthcare - Cartago.
[119786368]
The reported lot numbers are r17g18057 and r17k18068. (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[119786409]
It was reported that a y-type tur irrigation set would not flow. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[123526035]
Device manufacturing date: (b)(4) was manufactured 07/19/2017. Device manufacturing date: (b)(4) was manufactured 11/20/2017. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of these lots. The devices were not received for evaluation; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[123526036]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2018-05738 |
| MDR Report Key | 7857868 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-07 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-07-26 |
| Date Mfgr Received | 2018-10-08 |
| Date Added to Maude | 2018-09-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 - CARTAGO |
| Manufacturer Street | SEE H10 SEE H10 |
| Manufacturer City | CARTAGO 30106 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 30106 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TUR IRRIGATION SET |
| Generic Name | SYSTEM, IRRIGATION, UROLOGICAL |
| Product Code | LJH |
| Date Received | 2018-09-07 |
| Model Number | NA |
| Catalog Number | 2C4005 |
| Lot Number | ASKU |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - CARTAGO |
| Manufacturer Address | CARTAGO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-07 |