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U.S. Department of Health and Human Services

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

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UNOMEDICAL LTD. UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER; URINOMETER, MECHANICAL Back to Search Results
Model Number 15810130190
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2014
Event Type  malfunction  
Event Description
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.
 
Manufacturer Narrative
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).
 
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Brand Name
UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER
Type of Device
URINOMETER, MECHANICAL
Manufacturer (Section D)
UNOMEDICAL LTD.
zavodskaya street 50
fanipol
dzerzhinsk district minsk region 22275 0
BO  222750
Manufacturer Contact
matthew walenciak, interim assoca
211 american ave
greensboro, NC 27409
9083779293
MDR Report Key4426015
MDR Text Key5281008
Report Number3007966929-2015-00005
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 12/16/2014
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 Model Number15810130190
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/16/2014
Initial Date FDA Received01/12/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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