MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-14 for CYSTOSCOPY IRRIGATION SET 2C4040 manufactured by Baxter Healthcare Corporation.
[175027435]
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[175027436]
It was reported nineteen (19) cysto/bladder irrigation sets were contaminated. It was further reported the tubing appeared to have "diffuse/random greyish-black discoloration that transverses the tubing laterally (when cut open for inspection). " there was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[179864999]
Additional information was added. Five (5) devices were received for evaluation. One (1) of the five samples was received having a cut on the tubing. A visual inspection was performed using the naked eye which observed a brown/yellow discoloration between the walls of the tubing, which caused a visual effect of contamination in the tubing. The discoloration was cosmetic in nature and no particulate matter (pm) was observed in the fluid path of the tubing. Therefore, the reported condition of pm in fluid path was not verified. Functional testing was not performed for this complaint. The other samples were not received for evaluation; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2019-07557 |
| MDR Report Key | 9587715 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-14 |
| Date of Report | 2020-02-17 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-01-27 |
| Date Added to Maude | 2020-01-14 |
| 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 |
| 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 | CYSTOSCOPY IRRIGATION SET |
| Generic Name | SYSTEM, IRRIGATION, UROLOGICAL |
| Product Code | LJH |
| Date Received | 2020-01-14 |
| Returned To Mfg | 2020-01-22 |
| Model Number | NA |
| Catalog Number | 2C4040 |
| Lot Number | ASKU |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-14 |