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 Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)

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

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

Expiration date: 05/2020.Mfg date: 06/2015.Height: (b)(6).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: may 13, 2016.

Event Description

Reporter stated a patient admitted to the intensive care unit (icu) required connection to foley catheter and urine collection with device.On (b)(6), the healthcare professionals identified urine sediments in the space between the catheter connector and the first non-return valve.The device was changed due to the high risk of urinary infection related to the catheter.No further information was provided.

Manufacturer Narrative

A batch record indicates that no non-conformances and deviations related to complaint issue were initiated.The batch record review resulted in a discrepancy which was investigated and has been closed.Sterilization was performed in accordance with parameters.The investigation concludes that the likely root cause for the issue "stop flow between patient and chamber of unometer product" cannot be identified on the basis of the information received.No corrective actions are required at the this time.No additional investigation is needed.It was reported that the device was used during 9 days.The recommended period of usage is 7 days.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).

Manufacturer Narrative

This report is to further clarify, that there was a discrepancy found during a previous associated investigation, which is closed.The batch record for this reported event did not reveal any discrepancies/deviations that were related to the complaint issue.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 & 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: 5655004
• MDR Text Key: 45199553
• Report Number: 3007966929-2016-00038
• 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,Followup
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• 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: 08/17/2016
• 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: 74 YR
• Patient Weight: 45