MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS - WITH LUER-LOCK; DEVICE, URINE FLOW RATE MEASURING

Model Number 158100140190

Device Problems Improper Flow or Infusion (2954); Infusion or Flow Problem (2964); Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

Expiration date: 05/2020.Manufacturing date: 06/2015.Based on the available information, this event is deemed a reportable malfunction.No patient harm was reported.Additional information has been requested but has not been received to date.When additional information becomes available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported that a patient was admitted to the intensive care unit (icu) with renal failure and pancreatitis on (b)(6) 2016 who required connection to the device for output measurement as a part of hemodialysis therapy.The reporter stated that "on (b)(6) 2016, the physicians identified slow urinary flow from the measuring chamber to the collection bag.They opened the blue lever several times but there is no urine flow.During observation of the patient, they identify urinary sediment." the device was changed.No further information including treatment or outcome.

• Brand Name: UNOMETER SAFETI PLUS - WITH LUER-LOCK
• Type of Device: DEVICE, URINE FLOW RATE MEASURING
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street; 50 fanipol dzerzhinsk district; minsk region, minskaya voblast 22275 0; BO 222750
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5632777
• MDR Text Key: 44454117
• Report Number: 3007966929-2016-00032
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 158100140190
• Device Lot Number: 206060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2016
• 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 Number: 1
• Patient Age: 77 YR
• Patient Weight: 80