OTW INTL 14.5F 6903190

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 2020-02-14 for OTW INTL 14.5F 6903190 manufactured by Bard Access Systems.

MAUDE Entry Details

Report Number3006260740-2020-00534
MDR Report Key9714623
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-02-14
Date of Report2020-02-14
Date of Event2019-09-18
Date Mfgr Received2020-01-21
Date Added to Maude2020-02-14
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 ContactJUDITH LUDWIG
Manufacturer Street1415 W. 3RD STREET
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal85281
Manufacturer Phone4803032689
Manufacturer G1BARD REYNOSA S.A. DE C.V.
Manufacturer StreetBLVD MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL
Manufacturer CityREYNOSA TAMAULIPAS 88780
Manufacturer CountryMX
Manufacturer Postal Code88780
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOTW INTL 14.5F
Generic NameDIALYSIS CATHETER
Product CodeMSD
Date Received2020-02-14
Returned To Mfg2019-10-10
Catalog Number6903190
Lot NumberREDS3749
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBARD ACCESS SYSTEMS
Manufacturer Address605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-14

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