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 2018-07-03 for TUR IRRIGATION SET 2C4041 manufactured by Baxter Healthcare - Cartago.
[113020385]
(b)(6). (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[113020386]
It was reported that four units of irrigation sets presented clamp issues and as a result a patient experienced pain and was treated for the event. The issue occurred in the hospital while the irrigation set was in used post operatively. During treatment, the clamp opened easily with the pressure from the serum, causing two unspecified solutions to pass through at the same time and the bag filled up faster (no further detail was provided). The patient experienced pain and was treated with an unspecified analgesic. No further detail was provided regarding the patient? S outcome from the event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[120463688]
The actual device was not available; however, a photograph of the sample was provided for evaluation. The photograph was inspected and there was no evidence of an overflow. The reported condition could not be verified. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[120463689]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2018-04039 |
| MDR Report Key | 7658557 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-07-03 |
| Date of Report | 2018-08-06 |
| Date of Event | 2018-06-04 |
| Date Mfgr Received | 2018-08-01 |
| Device Manufacturer Date | 2018-03-20 |
| Date Added to Maude | 2018-07-03 |
| 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 | 2018-07-03 |
| Model Number | NA |
| Catalog Number | 2C4041 |
| Lot Number | R18C20028 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 1. Required No Informationntervention | 2018-07-03 |