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

Model Number 158101310190

Device Problem Occlusion Within Device (1423)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2014

Event Type  malfunction  

Event Description

The complainant states, she had difficulty emptying the unometer safti plus burette into the bottom drainage bag.After approximately eight (8) to ten (10) attempts of turning the tap, the burette then drained into the bottom drainage bag.The unometer safti plus was in use approximately three (3) days when the fault was noted.The unometer safti plus unit was removed and replaced with another unometer safti plus unit.

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.No additional pt or event details have been provided to date.Additional info was requested.Should additional info become available, a follow-up report will be submitted.Reported to the fda on (b)(4) 2014.

Manufacturer Narrative

Add'l information was received on may 07, 2015.Updated (device lot number).Returned used sample was received at the greensboro mfg site on (b)(6) 2015.No additional patient/event details have been provided to date.Should additional information become available, a f/u report will be submitted.

Manufacturer Narrative

Corrected data: section d.10, h.2 and h.3, information not reported on mdr mfr#3007966929-2014-00137 submitted 06/02/2015.Corrected data: batch review conducted and no discrepancies related to the complaint were noted.Information not reported on mdr mfr#3007966929-2014-00137 submitted on 06/26/2015.Additional information: visual inspection of received unused companion sample and no defects were identified.Flow rate test was performed and met specifications.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on december 15, 2015.

Manufacturer Narrative

A quality complaint investigation was performed.No non- conformance reports related to the complaint issue were initiated.The root cause investigation for the issue "stop flow between patient and chamber" was performed.The true root cause cannot be identified on the basis of information received.No corrective action is required at the moment.The used product was received and unable to be evaluated.(expiration date) and (device manufacture date) were updated based on new information received from investigation june 08, 2015.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on june 26, 2015.

• 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 22275 0; BO 222750
• Manufacturer Contact: matthew walenciak,interim assoc. ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4382150
• MDR Text Key: 5125214
• Report Number: 3007966929-2014-00137
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K896732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/09/2014

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 Expiration Date: 05/01/2019
• Device Model Number: 158101310190
• Device Lot Number: 159538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: 05/07/2015; 05/07/2015; 05/07/2015
• Supplement Dates FDA Received: 06/03/2015; 06/29/2015; 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1