UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER 158100410190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-06-01 for UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER 158100410190 manufactured by Unomedical Ltd..

Event Text Entries

[5930757] It was reported the flow from the unometer safeti plus to the collector bag was "very slow (slower than usual) and at some moments the device needed to be manipulated'. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[13416412] Based on the available information, this event is deemed a reportable malfunction. There were no reports of the patient being harmed as a result of this malfunction. Additional patient/event details have been requested. Should additional information become available, a follow-up report will be submitted. This complaint involves five devices, therefore a separate fda form 3500a will be drafted for each device.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3007966929-2015-00047
MDR Report Key4810775
Report Source01,05,06
Date Received2015-06-01
Date of Report2015-05-08
Date of Event2015-01-26
Date Mfgr Received2015-05-08
Date Added to Maude2015-06-22
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 FDA0
Event Location0
Manufacturer ContactMATTHEW WALENCIAK, INTERIM ASSOC.
Manufacturer Street211 AMERICAN AVE.
Manufacturer CityGREENSBORO NC 274090000
Manufacturer CountryUS
Manufacturer Postal274090000
Manufacturer Phone9083779293
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Product CodeEXR
Date Received2015-06-01
Model Number158100410190
Lot Number655189
Device Expiration Date2018-06-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerUNOMEDICAL LTD.
Manufacturer AddressZAVODSKAYA STREET 50 FANIPOL DZERZHINSK DISTRICT MINSK REGION 00002227 BO 000022275


Patients

Patient NumberTreatmentOutcomeDate
10 2015-06-01

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