MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-10-26 for ADVANCED VENOUS ACCESS CATHETER M3L9FHKI NA manufactured by Baxter Healthcare Corp..
Report Number | 6000002-1999-00314 |
MDR Report Key | 247629 |
Report Source | 06 |
Date Received | 1999-10-26 |
Date of Event | 1999-08-24 |
Date Mfgr Received | 1999-09-27 |
Date Added to Maude | 1999-11-03 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 0 |
Reprocessed and Reused Flag | 0 |
Health Professional | 0 |
Initial Report to FDA | 0 |
Report to FDA | 3 |
Event Location | 0 |
Manufacturer Contact | ALLISON MEZZANATTO |
Manufacturer Street | 17221 RED HILL AVE |
Manufacturer City | IRVINE CA 92614 |
Manufacturer Country | US |
Manufacturer Postal | 92614 |
Manufacturer Phone | 9492502562 |
Manufacturer G1 | * |
Manufacturer Street | * |
Manufacturer City | * |
Manufacturer Country | * |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ADVANCED VENOUS ACCESS CATHETER |
Generic Name | CENTRAL VENOUS CATHETER |
Product Code | JCY |
Date Received | 1999-10-26 |
Model Number | M3L9FHKI |
Catalog Number | NA |
Lot Number | UNK |
ID Number | NA |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 235232 |
Manufacturer | BAXTER HEALTHCARE CORP. |
Manufacturer Address | 17221 RED HILL AVE IRVINE CA 92614 US |
Baseline Brand Name | ADVANCED VENOUS ACCESS (AVA) CATHETER |
Baseline Generic Name | CENTRAL VENOUS ACCESS CATHETER |
Baseline Model No | M3L9FHKI |
Baseline Catalog No | NA |
Baseline ID | NA |
Baseline Shelf Life Contained | Y |
Baseline Shelf Life [Months] | 18 |
Baseline PMA Flag | N |
Baseline 510K PMN | Y |
Premarket Notification | K981909 |
Baseline Preamendment | N |
Baseline Transitional | N |
510k Exempt | N |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1999-10-26 |