MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-12-07 for MULTIPLE LUMEN ACCESS PRODUCT M3L9FHKI NA manufactured by Baxter Healthcare Corp..
| Report Number | 6000002-1999-00386 |
| MDR Report Key | 254795 |
| Report Source | 05,06 |
| Date Received | 1999-12-07 |
| Date of Event | 1999-11-09 |
| Date Mfgr Received | 1999-11-09 |
| Device Manufacturer Date | 1999-07-01 |
| Date Added to Maude | 1999-12-21 |
| 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 AVENUE |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502562 |
| Manufacturer G1 | * |
| Manufacturer Street | 1.4 KM STATE ROAD |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTIPLE LUMEN ACCESS PRODUCT |
| Generic Name | ADVANCED VENOUS ACCESS DEVICE |
| Product Code | JCY |
| Date Received | 1999-12-07 |
| Model Number | M3L9FHKI |
| Catalog Number | NA |
| Lot Number | 949G0983 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 246719 |
| Manufacturer | BAXTER HEALTHCARE CORP. |
| Manufacturer Address | 17221 RED HILL AVENUE 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 | 1. Other | 1999-12-07 |