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

Model Number 158100140190

Device Problem Collapse (1099)

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

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

Expiration date: 12/2020.Manufacture date: 01/2016.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.Reported to the fda on october 21, 2016.(b)(4).

Event Description

Complaint reporting a sampling port fault with the device after fifteen (15) days use.Reporter stated "the foley catheter collapsed as the nurse take the urine sample from the sampling port.They have tried to clamp the inlet tube for at least 2 hours and introduce air into the system, but they consider that this is a risk alternative that can cause infections on the patient.".

Manufacturer Narrative

A batch record review indicated that there were no discrepancies related to complaints issue and lot number.Device history records were reviewed.Sterilization was performed in accordance with parameters.The batch was released according to requirements.The batch record review resulted in a discrepancy which was investigated in another complaint (nc), which is now closed.However, the issue related to the foley catheter which is not part of product, cannot be evaluated by the manufacturing plant as the foley catheter that was collapsed has not been included in the shipped product.Therefore, it is not possible to assess impact to any areas/system/process.No additional investigation is needed.A video has been received for this complaint, which was evaluated.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.

• Brand Name: UNOMETER¿ SAFETI¿ PLUS - WITH LUER-LOCK & LUER
• Type of Device: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• 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: 6049020
• MDR Text Key: 58132257
• Report Number: 3007966929-2016-00097
• 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: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 158100140190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2016
• 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
• Treatment: AMIKACINE-DOSE, ROUTE AND FREQUENCY UNKNOWN; CEFTRIAZONE-DOSE, ROUTE AND FREQUENCY UNKNOWN
• Patient Age: 54 YR