NAVARRE UNIVERSAL DRAINAGE CATHETERS WITH NITINOL NNU8LPT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for NAVARRE UNIVERSAL DRAINAGE CATHETERS WITH NITINOL NNU8LPT manufactured by Bard Access Systems.

MAUDE Entry Details

Report Number3006260740-2020-00111
MDR Report Key9593578
Date Received2020-01-15
Date of Report2020-04-03
Date Mfgr Received2020-03-26
Date Added to Maude2020-01-15
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 ContactJUDITH LUDWIG
Manufacturer Street1415 W. 3RD STREET
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal85281
Manufacturer Phone4803032689
Manufacturer G1C.R. BARD, INC. (GFO)
Manufacturer Street289 BAY ROAD
Manufacturer CityQUEENSBURY NY 12804
Manufacturer CountryUS
Manufacturer Postal Code12804
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNAVARRE UNIVERSAL DRAINAGE CATHETERS WITH NITINOL
Generic NameDRAINAGE CATHETER
Product CodeGBX
Date Received2020-01-15
Catalog NumberNNU8LPT
Lot NumberGFDN4159, GFCW2179, UNKNOWN
Device Availability*
Device AgeDA
Device Eval'ed by Mfgr*
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 2020-01-15

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