UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER 15810130190

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 2015-01-12 for UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER 15810130190 manufactured by Unomedical Ltd..

Event Text Entries

[5281008] A health care professional reported the device was disconnected from the catheter. The disconnection caused urine to leak on the bed. The period of time the device was used when this incident occurred is unk.
Patient Sequence No: 1, Text Type: D, B5


[12869472] Based on the available info, this event is deemed a reportable malfunction. There were no reports of the pt being harmed as a result of this malfunction. It was also reported, "the lot number (156456) is the one the complainant gave me when first discussed the issues on the unit. She thinks the catheters came from this is the lot number. No bags or packaging were kept and so cannot definitely confirm this," thus the lot number reported is not being utilized to capture this event. Note: issue occurred on (12) separate cases. A separate 3500a form has been completed for the other (11) cases. Should add'l info become available, a follow up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3007966929-2015-00005
MDR Report Key4426015
Report Source01,05,06
Date Received2015-01-12
Date of Report2014-12-16
Date of Event2014-01-01
Date Mfgr Received2014-12-16
Date Added to Maude2015-02-02
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 FDA0
Event Location0
Manufacturer ContactMATTHEW WALENCIAK, INTERIM ASSOCA
Manufacturer Street211 AMERICAN AVE
Manufacturer CityGREENSBORO NC 27409
Manufacturer CountryUS
Manufacturer Postal27409
Manufacturer Phone9083779293
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER
Generic NameURINOMETER, MECHANICAL
Product CodeEXR
Date Received2015-01-12
Model Number15810130190
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 222750 BO 222750


Patients

Patient NumberTreatmentOutcomeDate
10 2015-01-12

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