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.
[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
Report Number | 6000002-2007-05640 |
MDR Report Key | 965842 |
Report Source | 01,05,06,07 |
Date Received | 2007-12-12 |
Date of Report | 2007-11-12 |
Date of Event | 2007-11-09 |
Date Facility Aware | 2007-11-09 |
Report Date | 2007-11-12 |
Date Mfgr Received | 2007-11-12 |
Date Added to Maude | 2008-04-02 |
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 | 3 |
Reporter Occupation | UNKNOWN |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | JODI TURPIN |
Manufacturer Street | ONE EDWARDS WAY |
Manufacturer City | IRVINE CA 92614 |
Manufacturer Country | US |
Manufacturer Postal | 92614 |
Manufacturer Phone | 9492502004 |
Manufacturer G1 | EDWARDS LIFESCIENCES |
Manufacturer Street | STATE ROAD 402 KM 1.4 INDUS. PK. |
Manufacturer City | ANASCO PR 00610 |
Manufacturer Country | US |
Manufacturer Postal Code | 00610 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ADVANCED VENOUS ACCESS CATHETER |
Generic Name | CENTRAL VENOUS ACCESS CATHETER |
Product Code | JCY |
Date Received | 2007-12-12 |
Model Number | M3L9FHSI |
Catalog Number | NA |
Lot Number | UNK |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | NA |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 972099 |
Manufacturer | EDWARDS LIFESCIENCES |
Manufacturer Address | ANASCO PR 00610 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2007-12-12 |