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

Model Number 158100140190

Device Problems Insufficient Flow or Under Infusion (2182); Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)

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

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

Height: 160cm.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 not 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 in the intensive care unit (icu), with thoracic trauma and renal failure was connected to a foley catheter and the device.The reporter stated that the device had been in use for seven (7) days when sediment was noted to be collecting in the tract before the non-return valve, and the urine flow had become slow.No further details were provided, including treatments and outcome.

Manufacturer Narrative

After detailed batch review, no discrepancies (includes non-conformances/deviations) were found.A nonconformance (nc) was opened.The nc has been closed as the root cause for the reported issue "stop flow between the patient and the chamber of the unometer product" could not be identified based on the information provided.Product monitoring reviews will monitor for product trends if the issue were to reoccur.Therefore, this complaint will be closed without further action.No additional patient/ event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

• 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: 5613656
• MDR Text Key: 43845151
• Report Number: 3007966929-2016-00027
• 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,Followup
• Report Date: 04/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• 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: 05/04/2016
• 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: 70 YR
• Patient Weight: 65