LEVEL 1 TRAUMA FAST FLOW DISPOSABLES DI-50

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-19 for LEVEL 1 TRAUMA FAST FLOW DISPOSABLES DI-50 manufactured by Smiths Medical Asd, Inc.

Event Text Entries

[184069667] Only the month (b)(6) and year (2019) of the event date are known. Device evaluation in progress.
Patient Sequence No: 1, Text Type: N, H10


[184069668] It was reported that the tubing would not prime at the lowest section of the tubing. The incident occurred prior to use with a patient. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-02147
MDR Report Key9853150
Report SourceFOREIGN,OTHER,USER FACILITY
Date Received2020-03-19
Date of Report2020-03-19
Date of Event2019-12-01
Date Mfgr Received2020-02-20
Date Added to Maude2020-03-19
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 ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS, MN
Manufacturer CountryUS
Manufacturer G1SMITHS MEDICAL ASD, INC
Manufacturer Street3350 GRANADA AVENUE NORTH SUITE 100
Manufacturer CityOAKDALE, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLEVEL 1 TRAUMA FAST FLOW DISPOSABLES
Generic NameWARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
Product CodeBSB
Date Received2020-03-19
Returned To Mfg2020-03-02
Catalog NumberDI-50
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS, MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.