4FR X 20CM SINGLE LUMEN CT MIDLINE BASIC TRAY VYML4S1001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-01 for 4FR X 20CM SINGLE LUMEN CT MIDLINE BASIC TRAY VYML4S1001 manufactured by Vygon Usa.

MAUDE Entry Details

Report Number2245270-2019-00060
MDR Report Key9139818
Report SourceHEALTH PROFESSIONAL
Date Received2019-10-01
Date of Report2019-11-07
Date of Event2019-09-22
Date Mfgr Received2019-09-23
Date Added to Maude2019-10-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactCLAIRE PADDOCK
Manufacturer Street2750 MORRIS ROAD
Manufacturer CityLANSDALE PA 19446
Manufacturer CountryUS
Manufacturer Postal19446
Manufacturer Phone8004735414
Manufacturer G1VYGON MFG
Manufacturer Street87 VENTURE DRIVE
Manufacturer CityDOVER NH 03820
Manufacturer CountryUS
Manufacturer Postal Code03820
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name4FR X 20CM SINGLE LUMEN CT MIDLINE BASIC TRAY
Generic NameMIDLINE CATHETER
Product CodePND
Date Received2019-10-01
Model NumberVYML4S1001
Catalog NumberVYML4S1001
Lot Number19G020D
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerVYGON USA
Manufacturer Address2750 MORRIS ROAD LANSDALE PA 19446 US 19446


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-01

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