MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-07-27 for TUR IRRIGATION SET 2C4041 manufactured by Baxter Healthcare - Cartago.
[81182800]
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[81182801]
It was reported that a y-type tur/bladder irrigation set leaked during infusion. The set was replaced to resolve the issue. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[104063916]
The sample was received for evaluation. Visual inspection, clear passage, and pressure testing were performed on the sample for analysis. During testing, a leak was confirmed from the assembly of the tubing into the drip housing. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The reported condition was verified. The cause was human error during the manual assembly process. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2017-06193 |
| MDR Report Key | 6747281 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-27 |
| Date of Report | 2017-09-01 |
| Date of Event | 2017-07-10 |
| Date Mfgr Received | 2017-08-09 |
| Device Manufacturer Date | 2017-01-03 |
| Date Added to Maude | 2017-07-27 |
| 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 | 2017-07-27 |
| Returned To Mfg | 2017-08-01 |
| Model Number | NA |
| Catalog Number | 2C4041 |
| Lot Number | R17A02070 |
| ID Number | NA |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - CARTAGO |
| Manufacturer Address | CARTAGO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-27 |