ADVANCED VENOUS ACCESS HIGH FLOW DEVICE 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 2001-12-18 for ADVANCED VENOUS ACCESS HIGH FLOW DEVICE M3L9FHKI NA manufactured by Edwards Lifesciences.

MAUDE Entry Details

• Report Number: 6000002-2001-00497
• MDR Report Key: 367694
• Report Source: 05,06,07
• Date Received: 2001-12-18
• Date of Event: 2001-11-23
• Date Mfgr Received: 2001-12-10
• Device Manufacturer Date: 2001-08-01
• Date Added to Maude: 2001-12-27
• 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
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: ALLISON MEZZANATTO
• Manufacturer Street: ONE EDWARDS WAY
• 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

Device Details

• Brand Name: ADVANCED VENOUS ACCESS HIGH FLOW DEVICE
• Generic Name: *
• Product Code: JCY
• Date Received: 2001-12-18
• Model Number: M3L9FHKI
• Catalog Number: NA
• Lot Number: *
• ID Number: NA
• Device Availability: *
• Device Age: 3 MO
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 356814
• Manufacturer: EDWARDS LIFESCIENCES
• Manufacturer Address: ROAD 402 NORTH 1.0 ANASCO PR 00610 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

Patients

Patient Number	Treatment	Outcome	Date
1	0		2001-12-18