ADVANCED VENOUS ACCESS M3L9FHKI NA

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number6000002-2000-00075
MDR Report Key269833
Report Source05,06,07
Date Received2000-03-17
Date of Report2000-02-17
Date of Event2000-02-08
Date Mfgr Received2000-02-17
Device Manufacturer Date1999-01-01
Date Added to Maude2000-03-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactALLISON MEZZANATTO
Manufacturer Street17221 RED HILL AVE
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9492502562
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADVANCED VENOUS ACCESS
Generic NameCENTRAL VENOUS ACCESS CATHETER
Product CodeJCY
Date Received2000-03-17
Model NumberM3L9FHKI
Catalog NumberNA
Lot Number949M0974
ID NumberNA
Device Expiration Date2000-07-01
Device AvailabilityN
Device AgeUNKNOWN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key261236
ManufacturerBAXTER HEALTHCARE CORP.
Manufacturer Address17221 RED HILL AVENUE IRVINE CA 92614 US
Baseline Brand NameADVANCED VENOUS ACCESS (AVA) CATHETER
Baseline Generic NameCENTRAL VENOUS ACCESS CATHETER
Baseline Model NoM3L9FHKI
Baseline Catalog NoNA
Baseline IDNA
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]18
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK981909
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2000-03-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.