MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2000-03-17 for ADVANCED VENOUS ACCESS M3L9FHKI NA manufactured by Baxter Healthcare Corp..
[193440]
It was reported that the stylet on the obturator from an ava kit broke at the hub while in vivo on a "do not resuscitate" pt. It was reported that the pt later died of multiple organ failures unrelated to the device. The obturator was inserted when the swan-ganz catheter was discontinued. When the ava catheter was discontinued, it was noted that 7 cm of the obturator stylet was missing. It was stated that the pt's expiration is unrelated to the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000002-2000-00075 |
| MDR Report Key | 269833 |
| Report Source | 05,06,07 |
| Date Received | 2000-03-17 |
| Date of Report | 2000-02-17 |
| Date of Event | 2000-02-08 |
| Date Mfgr Received | 2000-02-17 |
| Device Manufacturer Date | 1999-01-01 |
| Date Added to Maude | 2000-03-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 |
| Generic Name | CENTRAL VENOUS ACCESS CATHETER |
| Product Code | JCY |
| Date Received | 2000-03-17 |
| Model Number | M3L9FHKI |
| Catalog Number | NA |
| Lot Number | 949M0974 |
| ID Number | NA |
| Device Expiration Date | 2000-07-01 |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 261236 |
| 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 | 2000-03-17 |