MAUDE Adverse Event Report: TBD; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE

Model Number 509045

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Brand name: unometer safeti.Common name: device urine flow rate measuring, non electrical.Procode: (ffg).(b)(6).Based on the available information, this event is deemed a product malfunction.No patient harm was reported.Additional details have been requested but not provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).

Event Description

Complaint reported by a nurse that "the antireflux valve, does not allow to flow the urine through the tube (between the connector and the catheter)." the product was used, but no patient harm was reported.It was also reported that several boxes from the same lot were replaced by the sales rep at the request of the customer as a preventive measure.No further information is available.

Manufacturer Narrative

A batch record review was performed.A previous non-conformance is associated with this complaint, which is closed.The investigation concludes the likely root cause for the issue ¿stop flow between patient and chamber of unometer product¿ cannot be identified on the base of information received.No corrective action is required.No additional investigation is needed.This issue will be monitored through the post market product monitoring review process.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: TBD
• Type of Device: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• MDR Report Key: 6324024
• MDR Text Key: 67391204
• Report Number: 3007966929-2017-00003
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Model Number: 509045
• Device Lot Number: 210521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1