VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT G26489 IP-S5116W-MPIS-NT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-07 for VITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT G26489 IP-S5116W-MPIS-NT manufactured by Cook Vandergrift Inc.

MAUDE Entry Details

Report Number2522007-2020-00001
MDR Report Key9559831
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-01-07
Date of Report2020-01-07
Date of Event2019-12-06
Date Mfgr Received2019-12-10
Device Manufacturer Date2016-08-23
Date Added to Maude2020-01-07
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 ContactMR. BRIAN JOHNSTON
Manufacturer Street1186 MONTGOMERY LANE
Manufacturer CityVANDERGRIFT PA 15690
Manufacturer CountryUS
Manufacturer Postal15690
Manufacturer Phone7248458621
Manufacturer G1COOK VANDERGRIFT INC
Manufacturer Street1186 MONTGOMERY LANE
Manufacturer CityVANDERGRIFT PA 15690
Manufacturer CountryUS
Manufacturer Postal Code15690
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITAL-PORT DETACHED SILICONE CATHETER TITANIUM INFUSION PORT
Generic NameDWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Product CodeDWF
Date Received2020-01-07
Model NumberG26489
Catalog NumberIP-S5116W-MPIS-NT
Lot NumberN139904
Device Expiration Date2019-07-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCOOK VANDERGRIFT INC
Manufacturer Address1186 MONTGOMERY LANE VANDERGRIFT PA 15690 US 15690


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-07

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