SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN) N/A 900013B01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-31 for SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN) N/A 900013B01 manufactured by Bard Access Systems.

MAUDE Entry Details

Report Number3006260740-2019-03422
MDR Report Key9264239
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-10-31
Date of Report2019-10-31
Date of Event2019-09-15
Date Mfgr Received2019-10-09
Device Manufacturer Date2019-02-01
Date Added to Maude2019-10-31
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 ContactKAYLA OLSEN
Manufacturer Street605 N. 5600 W.
Manufacturer CitySALT LAKE CITY UT 84116
Manufacturer CountryUS
Manufacturer Postal84116
Manufacturer Phone8015225010
Manufacturer G1BARD REYNOSA S.A. DE C.V. -9617592
Manufacturer StreetBLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL
Manufacturer CityREYNOSA, TAMAULIPAS
Manufacturer CountryMX
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN)
Generic NameTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Product CodeITX
Date Received2019-10-31
Model NumberN/A
Catalog Number900013B01
Lot NumberREDP1903
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
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 2019-10-31

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