MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-18 for MULTI-PATIENT DISP SET ADVANTA MEDRAD AVANTA AVA 500 MPAT manufactured by Medrad Inc..
[925294]
White precipitant forming in medrad avanta fluid management injection system, designed for multi-patient use. Occurred multiple times over a period of over a week. All lot numbers of medrad avanta seem to be the same. Isovue 370 involved in all cases but lot numbers have differed. Isovue 370 has been in use for many years without problem. Isovue bottles appear completely sealed and without visible cracks. Isovue has no appearance of precipitate before entering medrad disposable set. This is a new event, we have not seen this type precipitate using earlier medrad systems designed for single use. Dose or amount #1 and #2. Na. Dates of use: #1. 2008. #2. 2000 - 2008. Diagnosis or reason for use: #1. Radiocontrast administration device. #2. Radiocontrast. Event reappeared after reintroduction? #1 and #2. Yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008338 |
| MDR Report Key | 1167211 |
| Date Received | 2008-09-18 |
| Date of Report | 2008-09-18 |
| Date of Event | 2008-09-12 |
| Date Added to Maude | 2008-09-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTI-PATIENT DISP SET ADVANTA |
| Generic Name | MEDRAD ADVANTA |
| Product Code | DXT |
| Date Received | 2008-09-18 |
| Returned To Mfg | 2008-09-12 |
| Model Number | MEDRAD AVANTA |
| Catalog Number | AVA 500 MPAT |
| Lot Number | 83032 |
| ID Number | 0616258001463 |
| Device Expiration Date | 2009-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1201101 |
| Manufacturer | MEDRAD INC. |
| Manufacturer Address | ONE MEDRAD DR. INDIANOLA PA 15051 US |
| Brand Name | ISOVUE 370 |
| Generic Name | NA |
| Product Code | KTA |
| Date Received | 2008-09-18 |
| Returned To Mfg | 2008-09-12 |
| Lot Number | MULTIPLE |
| ID Number | 0616258001463 |
| Device Expiration Date | 2009-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 2 |
| Device Event Key | 1201102 |
| Manufacturer | BRACCO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-18 |