MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-13 for TUR IRRIGATION SET 2C4041 manufactured by Baxter Healthcare Corporation.
[174887040]
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[174887041]
It was reported that "black dots" were observed embedded on the tubing of a y-type tur/bladder irrigation set. This was identified during an unspecified process step. 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
[179863905]
Additional information was added. The actual device was not available; however, a photograph of the sample was provided for evaluation. The returned photograph was reviewed, and it was noted that there was discoloration present between the walls of the tubing; however, the discoloration did not represent non-conforming product. There was no contamination or particulate matter observed in the fluid path. The reported condition was not verified. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2019-07533 |
| MDR Report Key | 9582566 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-13 |
| Date of Report | 2020-02-14 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-01-13 |
| 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 | 2020-01-13 |
| Model Number | NA |
| Catalog Number | 2C4041 |
| Lot Number | ASKU |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-13 |