ADVANCED VENOUS ACCESS CATHETER M3L9FHSI NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2007-12-12 for ADVANCED VENOUS ACCESS CATHETER M3L9FHSI NA manufactured by Edwards Lifesciences.

Event Text Entries

[20347769] It was reported that when the clinician drew back solution from the distal lumen line, bubbles were observed. Customer questioned if it was attributed to the hemostasis valve.
Patient Sequence No: 1, Text Type: D, B5


[20402095] Device has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number6000002-2007-05640
MDR Report Key965842
Report Source01,05,06,07
Date Received2007-12-12
Date of Report2007-11-12
Date of Event2007-11-09
Date Facility Aware2007-11-09
Report Date2007-11-12
Date Mfgr Received2007-11-12
Date Added to Maude2008-04-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationUNKNOWN
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJODI TURPIN
Manufacturer StreetONE EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9492502004
Manufacturer G1EDWARDS LIFESCIENCES
Manufacturer StreetSTATE ROAD 402 KM 1.4 INDUS. PK.
Manufacturer CityANASCO PR 00610
Manufacturer CountryUS
Manufacturer Postal Code00610
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADVANCED VENOUS ACCESS CATHETER
Generic NameCENTRAL VENOUS ACCESS CATHETER
Product CodeJCY
Date Received2007-12-12
Model NumberM3L9FHSI
Catalog NumberNA
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeNA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key972099
ManufacturerEDWARDS LIFESCIENCES
Manufacturer AddressANASCO PR 00610 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2007-12-12

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