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 2017-08-08 for TUR IRRIGATION SET 2C4041 manufactured by Baxter Healthcare - Cartago.
[82071573]
(b)(4). The device has been received and the evaluation is in progress. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[82071574]
It was reported that a hole was discovered? On the route? And a leak occurred from an irrigation set. The event occurred after opening the package. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[104060994]
The device was returned and an evaluation is complete. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Visual inspection was performed and noted a leak between the assembly of the tubing into the drip housing and a cut in the drip housing. Pressure test and clear passage underwater were performed and verified the leak from the two problem areas. The reported condition was verified and the cause is attributed to human error during production. In order to detect and prevent leak condition, there are controls in place during the manufacturing process such as visual inspection, leak test and functional testing based on product specifications, sampling plans according to the quality attribute to test and test method for inspections. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2017-06484 |
| MDR Report Key | 6774658 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-08 |
| Date of Report | 2017-08-29 |
| Date of Event | 2017-07-10 |
| Date Mfgr Received | 2017-08-09 |
| Device Manufacturer Date | 2017-01-03 |
| Date Added to Maude | 2017-08-08 |
| 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 - 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 | 2017-08-08 |
| Returned To Mfg | 2017-08-01 |
| Model Number | NA |
| Catalog Number | 2C4041 |
| Lot Number | R17A02070 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2017-08-08 |