MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-14 for CONTRAST CONTROLLER-SPIKE ASSEMBLY H965904000390 manufactured by Navilyst Medical Inc..
[22097169]
After injecting contrast in from a 500cc bottle it was noted that in the contrast and in the contrast spike that contrast spike had formed white particulates. A 125ml contrast bottle was then spiked and was used for one procedure. (new spike and new bottle were utilized) the same white particulates were also seen. ====================== health professional's impression======================not applicable
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920528 |
| MDR Report Key | 1920528 |
| Date Received | 2010-11-14 |
| Date of Report | 2010-11-13 |
| Date of Event | 2010-09-09 |
| Report Date | 2010-11-13 |
| Date Reported to FDA | 2010-11-14 |
| Date Added to Maude | 2010-12-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTRAST CONTROLLER-SPIKE ASSEMBLY |
| Generic Name | CONTRAST CONTROLLER-SPIKE ASSEMBLY |
| Product Code | FPA |
| Date Received | 2010-11-14 |
| Model Number | NA |
| Catalog Number | H965904000390 |
| Lot Number | 4054860 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 0 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NAVILYST MEDICAL INC. |
| Manufacturer Address | 10 GLENS FALLS TECHNICAL PARK GLENS FALLS NY 12801 US 12801 |
| Brand Name | 37% ORGANICALLY BOUND IODINE; ISOVUE-370 |
| Generic Name | 37% ORGANICALLY BOUND IODINE; ISOVUE-370 |
| Product Code | KTA |
| Date Received | 2010-11-14 |
| Model Number | * |
| Catalog Number | NDC 0270-1316-04 |
| Lot Number | 0B50299 |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BRACCO DIAGNOSTICS |
| Manufacturer Address | 107 COLLEGE ROAD EAST PRINCETON NJ 08540662 US 08540 6626 |
| Brand Name | 37% ORGANICALLY BOUND IODINE |
| Generic Name | 37% ORGANICALLY BOUND IODINE |
| Product Code | KTA |
| Date Received | 2010-11-14 |
| Model Number | NA |
| Catalog Number | NDC 0270-1316-98 |
| Lot Number | 9K38753 |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | BRACCO DIAGNOSTICS |
| Manufacturer Address | 107 COLLEGE ROAD EAST PRINCETON NJ 08540662 US 08540 6626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-14 |