MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-09-24 for DIALYSIS ADMINISTRATION SET 5M4484M manufactured by Baxter Healthcare Corp..
[22319]
No clamp on venous tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009979 |
| MDR Report Key | 39627 |
| Date Received | 1996-09-24 |
| Date of Report | 1996-09-12 |
| Date of Event | 1996-08-22 |
| Date Added to Maude | 1996-09-27 |
| 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 | 0 |
| Reporter Occupation | OTHER CAREGIVERS |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIALYSIS ADMINISTRATION SET |
| Generic Name | DIALYSIS ADMINISTRATION SET |
| Product Code | FJX |
| Date Received | 1996-09-24 |
| Model Number | 5M4484M |
| Catalog Number | 5M4484M |
| Lot Number | YGE099 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 40766 |
| Manufacturer | BAXTER HEALTHCARE CORP. |
| Manufacturer Address | 1620 WAUKEGAN MCGAW PARK IL 60085 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-09-24 |