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 |