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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER; URINOMETER, MECHANICAL

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UNOMEDICAL LTD. UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER; URINOMETER, MECHANICAL Back to Search Results
Model Number 158101310190
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/20/2015
Event Type  malfunction  
Event Description
The complainant reports the unometer safeti plus was connected to the patient's silicone urinary catheter at approximately 5:00 pm on (b)(6) 2015 and 'became disconnected' from the device within thirty minutes.The complainant further reports the device was discontinued at approximately 5:30 pm on (b)(6) 2015.
 
Manufacturer Narrative
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.(b)(4).
 
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Brand Name
UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER
Type of Device
URINOMETER, MECHANICAL
Manufacturer (Section D)
UNOMEDICAL LTD.
zavodskaya street 50
fanipol
dzerzhinsk district minsk region 00002 2275
BY  0000222750
Manufacturer Contact
matthew walenciak
211 american ave
greensboro, NC 27409
9083779293
MDR Report Key4487591
MDR Text Key5496902
Report Number3007966929-2015-00024
Device Sequence Number1
Product Code EXR
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K896732
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/01/2015
Device Model Number158101310190
Device Lot Number170548
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/22/2015
Initial Date FDA Received02/04/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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