ADVANCED VENOUS ACCESS CATHETER M3L9FHKI NA

MAUDE Adverse Event Report

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..

MAUDE Entry Details

Report Number6000002-1999-00314
MDR Report Key247629
Report Source06
Date Received1999-10-26
Date of Event1999-08-24
Date Mfgr Received1999-09-27
Date Added to Maude1999-11-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location0
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 CATHETER
Generic NameCENTRAL VENOUS CATHETER
Product CodeJCY
Date Received1999-10-26
Model NumberM3L9FHKI
Catalog NumberNA
Lot NumberUNK
ID NumberNA
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key235232
ManufacturerBAXTER HEALTHCARE CORP.
Manufacturer Address17221 RED HILL AVE 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
10 1999-10-26

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