VAMP PLUS VP1447TS02(PL)_

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for VAMP PLUS VP1447TS02(PL)_ manufactured by Edwards Lifesciences Dr.

Event Text Entries

[143083271] The device evaluation is anticipated. However the complaint cannot not be confirmed without the completion of a product evaluation. A supplemental report will be forthcoming with the evaluation and device history results when received.
Patient Sequence No: 1, Text Type: N, H10


[143083272] It was reported that a hair-like material was found inside of the vamp plus syringe before use. Patient demographic information requested but unavailable. There were no patient complications reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2015691-2019-01426
MDR Report Key8542028
Date Received2019-04-23
Date of Report2019-04-03
Date of Event2019-04-03
Date Mfgr Received2019-05-14
Device Manufacturer Date2018-03-14
Date Added to Maude2019-04-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS LYNN THOMAS
Manufacturer Street1 EDWARDS WAY
Manufacturer CityIRVINE CA 92614
Manufacturer CountryUS
Manufacturer Postal92614
Manufacturer Phone9497564386
Manufacturer G1EDWARDS LIFESCIENCES DR
Manufacturer StreetPARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5
Manufacturer CityHAINA, SAN CRISTOBAL
Manufacturer CountryDR
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameVAMP PLUS
Generic NameKIT, SAMPLING, ARTERIAL BLOOD
Product CodeCBT
Date Received2019-04-23
Returned To Mfg2019-05-07
Model NumberVP1447TS02(PL)_
Lot NumberKN1643MT
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerEDWARDS LIFESCIENCES DR
Manufacturer AddressPARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 HAINA, SAN CRISTOBAL DR


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-23

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