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 2018-12-19 for TUR IRRIGATION SET ARC4005P manufactured by Baxter Healthcare - Cali.
[130918758]
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
[130918759]
It was reported that the clamp of a tur irrigation set was missing. The missing clamp? Was identified before to patients use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[133371258]
The device was received for evaluation. A visual inspection was made and it was observed that the sample was correctly assembled and packed according to local specifications. Additionally, the lower clamp was absent. The reported condition was verified. The cause of the condition was related to human production during manufacturing. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. A nonconformance has been opened to address this issue. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[133371259]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2018-07906 |
| MDR Report Key | 8181552 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-12-19 |
| Date of Report | 2019-01-16 |
| Date Mfgr Received | 2018-12-22 |
| Device Manufacturer Date | 2018-09-24 |
| Date Added to Maude | 2018-12-19 |
| 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 | PHARMACIST |
| 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 | TUR IRRIGATION SET |
| Generic Name | SYSTEM, IRRIGATION, UROLOGICAL |
| Product Code | LJH |
| Date Received | 2018-12-19 |
| Returned To Mfg | 2018-12-06 |
| Model Number | NA |
| Catalog Number | ARC4005P |
| Lot Number | SE18IM1 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - CALI |
| Manufacturer Address | CALI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-19 |