FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN) N/A 5678200

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 2019-03-22 for FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN) N/A 5678200 manufactured by Bard Access Systems.

Event Text Entries

[140667688] The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10


[140667689] It was reported that the needle was stuck with guidewire, whole set was removed and it was noted the guide wire coil spring was separated from the core wire structure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006260740-2019-00629
MDR Report Key8444689
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-03-22
Date of Report2019-04-03
Date of Event2019-02-10
Date Mfgr Received2019-03-29
Date Added to Maude2019-03-22
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 ContactKELSEY ERICKSON
Manufacturer Street605 N. 5600 W.
Manufacturer CitySALT LAKE CITY UT 84116
Manufacturer CountryUS
Manufacturer Postal84116
Manufacturer Phone8015225937
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 NameFLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN)
Generic NameCATHETER, SUBCLAVIAN
Product CodeLFJ
Date Received2019-03-22
Returned To Mfg2019-03-18
Model NumberN/A
Catalog Number5678200
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
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 2019-03-22

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