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 Disconnection (1171)

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

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

Expiration date (12/2020).Manufacturing 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 20, 2016.(b)(4).

Event Description

Complaint reporting that "the nurse was going to empty the measuring chamber and as the blue lever was opened, the catheter disconnected from the measuring chamber, splashing the urine on the nurse's clothing." the use of the device was suspended, no additional treatment was required.No further details have been provided.

Manufacturer Narrative

Device history records were reviewed.Sterilization was performed in accordance with parameters.The batch was released according to requirements.A batch record review indicates no non-conformances are related to the complaint issue.The batch record review resulted in a discrepancy which was investigated in another complaint and is closed.On the basis of information received the investigation concludes that the true root cause for the issue "the inlet tube is detached from the measurement chamber" cannot be identified.No additional investigation is needed.A photograph 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.Reported to the fda on november 03, 2016.(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 voblasts 22275 0; BO 222750
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 6045630
• MDR Text Key: 58026228
• Report Number: 3007966929-2016-00095
• 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,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• 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: 220378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2016
• 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: 56 YR
• Patient Weight: 54