MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-02-07 for QUINTON CATHETER 2N3378 manufactured by Baxter Healthcare Corp..
[781402]
Quinton catheter iv tubing (broke) came apart. Rt femoral quinton site patent, catheter flushed easily & clamped. Pt found in pool of blood & pt required 2 units of prbc's to be transfused.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005347 |
| MDR Report Key | 997145 |
| Date Received | 2008-02-07 |
| Date of Report | 2008-01-22 |
| Date of Event | 2007-12-31 |
| Date Added to Maude | 2008-02-21 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUINTON CATHETER |
| Generic Name | IV TUBE |
| Product Code | LFK |
| Date Received | 2008-02-07 |
| Model Number | 2N3378 |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 968131 |
| Manufacturer | BAXTER HEALTHCARE CORP. |
| Manufacturer Address | ROUNDLAKE IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-02-07 |